cryoconcepts.comFreeze Point & Private Label Versions
Cryoconcepts LP
CRYOCONCEPTS LP
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008812068 | 3008812068 | CRYOCONCEPTS LP | 1 | N | 2026-01-01 | 1100 Conroy Place Easton PA US 18040 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850077006081 | Histofreezer - Histofreezer, Kit, U.S., 40T1CThe Histofreezer Portable Cryosurgical System is used for the removal of warts and other benign skin lesions: Genital Lesions, Molluscum Contagiosum, Seborrheic Keratoses, Skin Tags, Verruca Plantaris, Verruca Vulgaris, Verruca Plana, Actinic Keratoses (Facial and Non-Facial), and Lentigo (Facial and Non-Facial). The Histofreezer System should only be supplied to and used by medically trained healthcare professionals. | 1-855-355-2796 | support@cryoconcepts.com |
| 00850077006098 | Histofreezer - Histofreezer, Kit U.S, 36F1CThe Histofreezer Portable Cryosurgical System is used for the removal of warts and other benign skin lesions: Genital Lesions, Molluscum Contagiosum, Seborrheic Keratoses, Skin Tags, Verruca Plantaris, Verruca Vulgaris, Verruca Plana, Actinic Keratoses (Facial and Non-Facial), and Lentigo (Facial and Non-Facial). The Histofreezer System should only be supplied to and used by medically trained healthcare professionals. | 1-855-355-2796 | support@cryoconcepts.com |
| 00850077006104 | Histofreezer - Histofreezer, Kit, U.S., 36M1CThe Histofreezer Portable Cryosurgical System is used for the removal of warts and other benign skin lesions: Genital Lesions, Molluscum Contagiosum, Seborrheic Keratoses, Skin Tags, Verruca Plantaris, Verruca Vulgaris, Verruca Plana, Actinic Keratoses (Facial and Non-Facial), and Lentigo (Facial and Non-Facial). The Histofreezer System should only be supplied to and used by medically trained healthcare professionals. | 1-855-355-2796 | support@cryoconcepts.com |
| 00850077006111 | Histofreezer - Histofreezer, Kit, U.S., 5M1CThe Histofreezer Portable Cryosurgical System is used for the removal of warts and other benign skin lesions: Genital Lesions, Molluscum Contagiosum, Seborrheic Keratoses, Skin Tags, Verruca Plantaris, Verruca Vulgaris, Verruca Plana, Actinic Keratoses (Facial and Non-Facial), and Lentigo (Facial and Non-Facial). The Histofreezer System should only be supplied to and used by medically trained healthcare professionals. | 1-855-355-2796 | support@cryoconcepts.com |
| 00850077006128 | Histofreezer - Histofreezer, Kit, U.S., 60MC2 + 10The Histofreezer Portable Cryosurgical System is used for the removal of warts and other benign skin lesions: Genital Lesions, Molluscum Contagiosum, Seborrheic Keratoses, Skin Tags, Verruca Plantaris, Verruca Vulgaris, Verruca Plana, Actinic Keratoses (Facial and Non-Facial), and Lentigo (Facial and Non-Facial). The Histofreezer System should only be supplied to and used by medically trained healthcare professionals. | 1-855-355-2796 | support@cryoconcepts.com |
| 00850077006340 | Histofreezer FLEX - Histofreezer FLEX Kit 50SB Small Bud Kit. The Histofreezer FLEX is intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The following are examples of the types of lesions that may be treated: Verruca (warts), Plantar warts, Seborrheic Keratoses, Actinic Keratoses, Achrochordon, Molluscum Contagiosum, Age Spots, Dermafibroma, Small Keloids, Granuloma Annulare, Porokeratosis Plantaris, Angiomas, Lentigo Maligna, Keratoacanthoma, Bowen’s Disease, Lentigo Discrete, Chondrodermatitis, Epithelial Nevus, Leukoplakia, Granuloma Pyogenicum and Pyogenic Granuloma. The Histofreezer FLEX should only be supplied to and used by licensed practitioners. | 1-855-355-2796 | support@cryoconcepts.com |
| 00850077006357 | Histofreezer FLEX - Histofreezer FLEX Kit 50SC Small Cone Kit. The Histofreezer FLEX is intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The following are examples of the types of lesions that may be treated: Verruca (warts), Plantar warts, Seborrheic Keratoses, Actinic Keratoses, Achrochordon, Molluscum Contagiosum, Age Spots, Dermafibroma, Small Keloids, Granuloma Annulare, Porokeratosis Plantaris, Angiomas, Lentigo Maligna, Keratoacanthoma, Bowen’s Disease, Lentigo Discrete, Chondrodermatitis, Epithelial Nevus, Leukoplakia, Granuloma Pyogenicum and Pyogenic Granuloma. The Histofreezer FLEX should only be supplied to and used by licensed practitioners. | 1-855-355-2796 | support@cryoconcepts.com |
| 00850077006364 | Histofreezer FLEX - Histofreezer FLEX Kit 50SM Small Mixed Kit. The Histofreezer FLEX is intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The following are examples of the types of lesions that may be treated: Verruca (warts), Plantar warts, Seborrheic Keratoses, Actinic Keratoses, Achrochordon, Molluscum Contagiosum, Age Spots, Dermafibroma, Small Keloids, Granuloma Annulare, Porokeratosis Plantaris, Angiomas, Lentigo Maligna, Keratoacanthoma, Bowen’s Disease, Lentigo Discrete, Chondrodermatitis, Epithelial Nevus, Leukoplakia, Granuloma Pyogenicum and Pyogenic Granuloma. The Histofreezer FLEX should only be supplied to and used by licensed practitioners. | 1-855-355-2796 | support@cryoconcepts.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 123244 | 1871577036 | K990877 | HISTOFREEZER DEVICE | GEH | 1999-06-14 |
| 123244 | 1280535065 | K982358 | HISTOFREEZER DEVICE | GEH | 1998-10-02 |
| 123244 | 1566723660 | K980739 | HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS | GEH | 1998-05-26 |
| 123244 | 1257450631 | K971392 | HISTOFREEZER VERRUCA PLANA | GEH | 1997-10-21 |
| 123244 | 1073220134 | K933327 | HISTOFREEZER | GEH | 1993-10-29 |
| 123244 | 2056349681 | K931299 | HISTOFREEZER | GEH | 1993-08-11 |
| 123244 | 1317421024 | K924114 | HISTOFREEZER | GEH | 1993-02-05 |
| 123244 | 1379218963 | K911420 | HISTOFREEZER | GEH | 1991-06-28 |
| 123244 | 2022406258 | K251493 | Skin Clinic Freeze Point for Warts and Skin Tags | GEH | 2025-05-22 |
| 123244 | 1813936411 | K242932 | Skin Clinic Nitro Clear Wart Remover | GEH | 2025-04-15 |
| 123244 | 1381738830 | K242625 | Freeze Point & Private Label Versions | GEH | 2024-10-25 |
| 123244 | 1216737082 | K211099 | Freeze’n Clear Skin Clinic Warts & Tags | GEH | 2022-06-17 |
| 123244 | 1859304043 | K190407 | CryoLab | GEH | 2019-04-22 |
| 123244 | 1343001977 | K183601 | CryoTouch | GEH | 2019-04-18 |
| 123244 | 1850407967 | K102006 | CRYOMEGA | GEH | 2010-10-06 |
| 123244 | 1825959391 | K023487 | HISTOFREEZER WART REMOVAL SYSTEM OR OTHER PROPRIETARY NAME | GEH | 2003-03-20 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GEH | 16 | 2025-05-22 |
PMN#
Histofreezer V
Cryoconcepts LP
Freeze’n Clear Skin Clinic Warts & Tags
CryoConcepts LP
CryoLab
CryoConcepts LP
CryoTouch
CryoConcepts LP
CryOmega Flexx
CryoConcepts LP
GUDID#
Histofreezer - Histofreezer, Kit, U.S., 40T1CThe Histofreezer Portable Cryosurgical System is used for the removal of warts and other benign skin lesions: Genital Lesions, Molluscum Contagiosum, Seborrheic Keratoses, Skin Tags, Verruca Plantaris, Verruca Vulgaris, Verruca Plana, Actinic Keratoses (Facial and Non-Facial), and Lentigo (Facial and Non-Facial). The Histofreezer System should only be supplied to and used by medically trained healthcare professionals.
2020-09-22
Histofreezer - Histofreezer, Kit U.S, 36F1CThe Histofreezer Portable Cryosurgical System is used for the removal of warts and other benign skin lesions: Genital Lesions, Molluscum Contagiosum, Seborrheic Keratoses, Skin Tags, Verruca Plantaris, Verruca Vulgaris, Verruca Plana, Actinic Keratoses (Facial and Non-Facial), and Lentigo (Facial and Non-Facial). The Histofreezer System should only be supplied to and used by medically trained healthcare professionals.
2020-06-24
Histofreezer - Histofreezer, Kit, U.S., 36M1CThe Histofreezer Portable Cryosurgical System is used for the removal of warts and other benign skin lesions: Genital Lesions, Molluscum Contagiosum, Seborrheic Keratoses, Skin Tags, Verruca Plantaris, Verruca Vulgaris, Verruca Plana, Actinic Keratoses (Facial and Non-Facial), and Lentigo (Facial and Non-Facial). The Histofreezer System should only be supplied to and used by medically trained healthcare professionals.
2020-09-22
Histofreezer - Histofreezer, Kit, U.S., 5M1CThe Histofreezer Portable Cryosurgical System is used for the removal of warts and other benign skin lesions: Genital Lesions, Molluscum Contagiosum, Seborrheic Keratoses, Skin Tags, Verruca Plantaris, Verruca Vulgaris, Verruca Plana, Actinic Keratoses (Facial and Non-Facial), and Lentigo (Facial and Non-Facial). The Histofreezer System should only be supplied to and used by medically trained healthcare professionals.
2020-09-22
Histofreezer FLEX - Histofreezer FLEX Kit 50SB Small Bud Kit. The Histofreezer FLEX is intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The following are examples of the types of lesions that may be treated: Verruca (warts), Plantar warts, Seborrheic Keratoses, Actinic Keratoses, Achrochordon, Molluscum Contagiosum, Age Spots, Dermafibroma, Small Keloids, Granuloma Annulare, Porokeratosis Plantaris, Angiomas, Lentigo Maligna, Keratoacanthoma, Bowen’s Disease, Lentigo Discrete, Chondrodermatitis, Epithelial Nevus, Leukoplakia, Granuloma Pyogenicum and Pyogenic Granuloma. The Histofreezer FLEX should only be supplied to and used by licensed practitioners.
2020-09-13
Histofreezer FLEX - Histofreezer FLEX Kit 50SC Small Cone Kit. The Histofreezer FLEX is intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The following are examples of the types of lesions that may be treated: Verruca (warts), Plantar warts, Seborrheic Keratoses, Actinic Keratoses, Achrochordon, Molluscum Contagiosum, Age Spots, Dermafibroma, Small Keloids, Granuloma Annulare, Porokeratosis Plantaris, Angiomas, Lentigo Maligna, Keratoacanthoma, Bowen’s Disease, Lentigo Discrete, Chondrodermatitis, Epithelial Nevus, Leukoplakia, Granuloma Pyogenicum and Pyogenic Granuloma. The Histofreezer FLEX should only be supplied to and used by licensed practitioners.
2020-09-13
Histofreezer FLEX - Histofreezer FLEX Kit 50SM Small Mixed Kit. The Histofreezer FLEX is intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The following are examples of the types of lesions that may be treated: Verruca (warts), Plantar warts, Seborrheic Keratoses, Actinic Keratoses, Achrochordon, Molluscum Contagiosum, Age Spots, Dermafibroma, Small Keloids, Granuloma Annulare, Porokeratosis Plantaris, Angiomas, Lentigo Maligna, Keratoacanthoma, Bowen’s Disease, Lentigo Discrete, Chondrodermatitis, Epithelial Nevus, Leukoplakia, Granuloma Pyogenicum and Pyogenic Granuloma. The Histofreezer FLEX should only be supplied to and used by licensed practitioners.
2020-09-13
Histofreezer - Histofreezer, Kit, U.S., 60MC2 + 10The Histofreezer Portable Cryosurgical System is used for the removal of warts and other benign skin lesions: Genital Lesions, Molluscum Contagiosum, Seborrheic Keratoses, Skin Tags, Verruca Plantaris, Verruca Vulgaris, Verruca Plana, Actinic Keratoses (Facial and Non-Facial), and Lentigo (Facial and Non-Facial). The Histofreezer System should only be supplied to and used by medically trained healthcare professionals.
2020-09-22
Histofreezer FLEX - Histofreezer FLEX Kit 80SM Small Mixed Kit. The Histofreezer FLEX is intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The following are examples of the types of lesions that may be treated: Verruca (warts), Plantar warts, Seborrheic Keratoses, Actinic Keratoses, Achrochordon, Molluscum Contagiosum, Age Spots, Dermafibroma, Small Keloids, Granuloma Annulare, Porokeratosis Plantaris, Angiomas, Lentigo Maligna, Keratoacanthoma, Bowen’s Disease, Lentigo Discrete, Chondrodermatitis, Epithelial Nevus, Leukoplakia, Granuloma Pyogenicum and Pyogenic Granuloma. The Histofreezer FLEX should only be supplied to and used by licensed practitioners.
2020-09-13
Histofreezer - Histofreezer, Kit, U.S., 40T1C The Histofreezer Portable Cryosurgical System is used for the removal of warts and other benign skin lesions: Genital Lesions, Molluscum Contagiosum, Seborrheic Keratoses, Skin Tags, Verruca Plantaris, Verruca Vulgaris, Verruca Plana, Actinic Keratoses (Facial and Non-Facial), and Lentigo (Facial and Non-Facial). The Histofreezer System should only be supplied to and used by medically trained healthcare professionals.
2020-09-22
Histofreezer - Histofreezer, Kit, U.S., 36M1C The Histofreezer Portable Cryosurgical System is used for the removal of warts and other benign skin lesions: Genital Lesions, Molluscum Contagiosum, Seborrheic Keratoses, Skin Tags, Verruca Plantaris, Verruca Vulgaris, Verruca Plana, Actinic Keratoses (Facial and Non-Facial), and Lentigo (Facial and Non-Facial). The Histofreezer System should only be supplied to and used by medically trained healthcare professionals.
2020-09-22
Histofreezer - Histofreezer, Kit, U.S., 5M1C The Histofreezer Portable Cryosurgical System is used for the removal of warts and other benign skin lesions: Genital Lesions, Molluscum Contagiosum, Seborrheic Keratoses, Skin Tags, Verruca Plantaris, Verruca Vulgaris, Verruca Plana, Actinic Keratoses (Facial and Non-Facial), and Lentigo (Facial and Non-Facial). The Histofreezer System should only be supplied to and used by medically trained healthcare professionals.
2020-09-22
Histofreezer FLEX - Histofreezer FLEX Kit 50SB Small Bud Kit. The Histofreezer FLEX is intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The following are examples of the types of lesions that may be treated: Verruca (warts), Plantar warts, Seborrheic Keratoses, Actinic Keratoses, Achrochordon, Molluscum Contagiosum, Age Spots, Dermafibroma, Small Keloids, Granuloma Annulare, Porokeratosis Plantaris, Angiomas, Lentigo Maligna, Keratoacanthoma, Bowen’s Disease, Lentigo Discrete, Chondrodermatitis, Epithelial Nevus, Leukoplakia, Granuloma Pyogenicum and Pyogenic Granuloma. The Histofreezer FLEX should only be supplied to and used by licensed practitioners.
2020-09-13
Histofreezer FLEX - Histofreezer FLEX Kit 50SC Small Cone Kit. The Histofreezer FLEX is intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The following are examples of the types of lesions that may be treated: Verruca (warts), Plantar warts, Seborrheic Keratoses, Actinic Keratoses, Achrochordon, Molluscum Contagiosum, Age Spots, Dermafibroma, Small Keloids, Granuloma Annulare, Porokeratosis Plantaris, Angiomas, Lentigo Maligna, Keratoacanthoma, Bowen’s Disease, Lentigo Discrete, Chondrodermatitis, Epithelial Nevus, Leukoplakia, Granuloma Pyogenicum and Pyogenic Granuloma. The Histofreezer FLEX should only be supplied to and used by licensed practitioners.
2020-09-13
Histofreezer FLEX - Histofreezer FLEX Kit 50SM Small Mixed Kit. The Histofreezer FLEX is intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The following are examples of the types of lesions that may be treated: Verruca (warts), Plantar warts, Seborrheic Keratoses, Actinic Keratoses, Achrochordon, Molluscum Contagiosum, Age Spots, Dermafibroma, Small Keloids, Granuloma Annulare, Porokeratosis Plantaris, Angiomas, Lentigo Maligna, Keratoacanthoma, Bowen’s Disease, Lentigo Discrete, Chondrodermatitis, Epithelial Nevus, Leukoplakia, Granuloma Pyogenicum and Pyogenic Granuloma. The Histofreezer FLEX should only be supplied to and used by licensed practitioners.
2020-09-13
Histofreezer - Histofreezer, Kit U.S, 36F1C The Histofreezer Portable Cryosurgical System is used for the removal of warts and other benign skin lesions: Genital Lesions, Molluscum Contagiosum, Seborrheic Keratoses, Skin Tags, Verruca Plantaris, Verruca Vulgaris, Verruca Plana, Actinic Keratoses (Facial and Non-Facial), and Lentigo (Facial and Non-Facial). The Histofreezer System should only be supplied to and used by medically trained healthcare professionals.
2020-06-24
CryOmega - The CryOmega is a disposable device intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The list below shows examples of the types of lesions of lesions that can be treated:• Actinic Keratosis• Genital Lesions• Lentigo• Molluscum Contagiosum• Seborrheic Keratoses• Skin Tags• Verruca Plana• Verruca Plantaris• Verruca VulgarisAngiomas• Acne (Cysts & Scars)• Scars (Keloids)• Angiomas• Spider Angiomas• Teleangiectases• Keratosis Pilaris (Milia)• Sebaceous HyperplasiaThe CryOmega is designed as a multi-use disposable, cryosurgical device that uses Nitrous Oxide (N2O) spray for the destruction of tissue.
2020-01-27
CryoLab Medical - The CryoLab® Medical device uses CryoConcepts’ design and technology to deliver a spray of either Nitrous Oxide or Carbon Dioxide gas respectively to treat topical cutaneous lesions. The intended use for the CryoLab®, for both gases, is the surgical destruction of target tissue by extreme cold temperatures. Specifically, example lesions the device is intended to treat, based upon the literature, include molluscum contagiosum, skin tags, actinic keratosis, lentigo, verruca plana, verruca vulgaris, verruca plantaris, genital lesions, and seborrheic keratosis.
2019-07-15
CryoLab Aesthetics - The CryoLab® Aesthetic device uses CryoConcepts’ design and technology to deliver a spray of Carbon Dioxide gas to treat topical cutaneous lesions. The intended use for the CryoLab® Aesthetics, is the surgical destruction of target tissue by extreme cold temperatures. Specifically, example lesions the device is intended to treat, based upon the literature, include skin tags, actinic keratosis, and seborrheic keratosis.
2019-07-03
CryOmega - The CryOmega is a disposable device intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The list below shows examples of the types of lesions that can be treated: • Genital Lesions • Molluscum Contagiosum • Seborrheic Keratoses • Skin Tags • Verruca Plantaris • Verruca Vulgaris • Verruca Plana • Actinic Keratosis • Lentigo • Acne (Cysts & Scars) • Scars (Keloids) • Angiomas • Spider Angiomas • Teleangiectases • Keratosis Pilaris (Milia) • Sebaceous Hyperplasia. The CryOmega is designed as a multi-use disposable, cryosurgical device that uses Nitrous Oxide (N2O) spray for the destruction of tissue.
2016-09-24
CryOmega - The CryOmega is a disposable device intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The list below shows examples of the types of lesions that can be treated: • Genital Lesions • Molluscum Contagiosum • Seborrheic Keratoses • Skin Tags • Verruca Plantaris • Verruca Vulgaris • Verruca Plana • Actinic Keratosis • Lentigo • Acne (Cysts & Scars) • Scars (Keloids) • Angiomas • Spider Angiomas • Teleangiectases • Keratosis Pilaris (Milia) • Sebaceous Hyperplasia. The CryOmega is designed as a multi-use disposable, cryosurgical device that uses Nitrous Oxide (N2O) spray for the destruction of tissue.
2016-09-24
CryOmega - The CryOmega is a disposable device intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The list below shows examples of the types of lesions that can be treated: • Genital Lesions • Molluscum Contagiosum • Seborrheic Keratoses • Skin Tags • Verruca Plantaris • Verruca Vulgaris • Verruca Plana • Actinic Keratosis • Lentigo • Acne (Cysts & Scars) • Scars (Keloids) • Angiomas • Spider Angiomas • Teleangiectases • Keratosis Pilaris (Milia) • Sebaceous Hyperplasia. The CryOmega is designed as a multi-use disposable, cryosurgical device that uses Nitrous Oxide (N2O) spray for the destruction of tissue.
2016-09-24
CryOmega - The CryOmega is a disposable device intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The list below shows examples of the types of lesions that can be treated: • Genital Lesions • Molluscum Contagiosum • Seborrheic Keratoses • Skin Tags • Verruca Plantaris • Verruca Vulgaris • Verruca Plana • Actinic Keratosis • Lentigo • Acne (Cysts & Scars) • Scars (Keloids) • Angiomas • Spider Angiomas • Teleangiectases • Keratosis Pilaris (Milia) • Sebaceous Hyperplasia. The CryOmega is designed as a multi-use disposable, cryosurgical device that uses Nitrous Oxide (N2O) spray for the destruction of tissue.
2016-09-24
CryoClear - The CryoClear™ is a multi-use disposable device intended for the removal of target tissue by applying cryogenic gases at extreme low temperatures. The list below shows examples of the types of lesions that can be treated. • Lentigo (Age Spots)• Skin Tags• Actinic Keratosis (Sun Spots)• Acne (Cysts & Scars)• Angiomas• Spider Angiomas• Teleangiectases• Keratosis Pilaris (Milia)• Sebaceous Hyperplasia
2016-09-24
CryoClear - The CryoClear™ is a multi-use disposable device intended for the removal of target tissue by applying cryogenic gases at extreme low temperatures. The list below shows examples of the types of lesions that can be treated. • Lentigo (Age Spots)• Skin Tags• Actinic Keratosis (Sun Spots)• Acne (Cysts & Scars)• Angiomas• Spider Angiomas• Teleangiectases• Keratosis Pilaris (Milia)• Sebaceous Hyperplasia
2016-09-24