FAQ? (302)
Foreo, Inc.
FOREO INC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012104022 | 3012104022 | FOREO INC | 1 | Y | 2026-01-01 | 1525 E Pama Lane Las Vegas NV US 89119 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 188606 | 1665964924 | K253683 | FAQ™ (LED Panel); FAQ™ (Dual LED Panel) | OHS | 2026-02-20 |
| 188606 | 1754422768 | K242747 | FAQ™ (302) | OAP | 2024-12-11 |
| 188606 | 1191246995 | K241102 | Luna 4 plus | OHS | 2024-08-20 |
| 188606 | 1894882150 | K240616 | FAQ™ (102) | PAY | 2024-07-15 |
| 188606 | 1105185971 | K240378 | FAQ™ 201, FAQ™ 202 | OHS | 2024-04-19 |
| 188606 | 1205532301 | K232242 | BEAR 2 Body | NFO | 2024-05-13 |
| 188606 | 1867794878 | K231977 | PEACH 2, PEACH 2 Duo, PEACH 2 go | OHT | 2023-09-25 |
| 188606 | 1885184448 | K222012 | FAQ 101 | PAY | 2023-04-05 |
| 188606 | 1672790527 | K200803 | BEAR and BEAR mini | NFO | 2020-07-31 |
| 188606 | 1834526062 | K162450 | ESPADA Acne-Clearing Blue Light Pen | OLP | 2016-11-30 |
| 188606 | 1631532769 | ||||
| 188606 | 1683752701 | ||||
| 188606 | 1925171241 |
Product Codes Associated With Registrations#
PMN#
Luna 4 plus
Foreo, Inc.
FAQ? (102)
Foreo, Inc.
BEAR 2 Body
Foreo, Inc.
FAQ? 201, FAQ? 202
Foreo, Inc.
PEACH 2, PEACH 2 Duo, PEACH 2 go
Foreo, Inc.
FAQ 101
Foreo, Inc.
BEAR And BEAR Mini
FOREO, Inc.
ESPADA Acne-Clearing Blue Light Pen
FOREO INC.
GUDID#
FAQ Dual LED Panel - FAQ LED Panels are over-the-counter (OTC) devices intended for the treatment of wrinkles with red+ infrared light and yellow + infrared light, and the treatment of mild to moderate acne with blue+infrared light.
2026-03-02
FAQ LED Panel - FAQ LED Panels are over-the-counter (OTC) devices intended for the treatment of wrinkles with red+ infrared light and yellow + infrared light, and the treatment of mild to moderate acne with blue+infrared light.
2026-03-02
ESPADA 2 Plus - ESPADA™ devices have been developed to be used as an at-home devices for the treatment of mild to moderate inflammatory acne on the facial area
2024-02-20
ESPADA 2 Plus - ESPADA™ devices have been developed to be used as an at-home devices for the treatment of mild to moderate inflammatory acne on the facial area
2024-02-20
BEAR 2 go - Bear 2 go is intended for facial and neck stimulation and are indicated for over-the-counter cosmetic use.
2024-03-07
BEAR 2 go - Bear 2 go is intended for facial and neck stimulation and are indicated for over-the-counter cosmetic use.
2024-03-07
BEAR 2 - Bear 2 is intended for facial and neck stimulation and are indicated for over-the-counter cosmetic use.
2024-03-07
BEAR 2 - Bear 2 is intended for facial and neck stimulation and are indicated for over-the-counter cosmetic use.
2024-03-07
BEAR 2 - Bear 2 is intended for facial and neck stimulation and are indicated for over-the-counter cosmetic use.
2024-03-07
BEAR 2 eyes & lips - Bear 2 eyes & lips is intended for facial and neck stimulation, and are indicated for over-the-counter cosmetic use.
2024-03-07
BEAR 2 eyes & lips - Bear 2 eyes & lips is intended for facial and neck stimulation and are indicated for over-the-counter cosmetic use.
2024-03-07
FAQ 202 Plus - FAQ™ 200 Plus is intended to use LED light for the treatment of wrinkles and mild to moderate acne.
2025-07-15
FAQ 101 - FAQ™ 101 device is an over-the-counter home use devices intended for non-invasive treatments of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-VI.
2024-03-01
FAQ 102 - FAQ™ 102 devices are over-the-counter home use devices intended for facial and neck skin stimulation, and non-invasive treatments of mild to moderate facial wrinkles for adult women with all skin tones.
2024-07-18
FAQ 103 - FAQ™ 103 devices are over-the-counter home use devices intended for facial and neck skin stimulation, and non-invasive treatments of mild to moderate facial wrinkles for adult women with all skin tones.
2024-07-18
FAQ 102 - FAQ™ 102 devices are over-the-counter home use devices intended for facial and neck skin stimulation, and non-invasive treatments of mild to moderate facial wrinkles for adult women with all skin tones.
2024-07-18
ISSA 4 Baby - ISSA 4 Baby is for use at home and to promote overall oral hygiene by cleaning your teeth and gums only.
2025-05-27
ISSA 4 Baby - ISSA 4 Baby is for use at home and to promote overall oral hygiene by cleaning your teeth and gums only.
2025-05-27
ISSA 4 Baby - ISSA 4 Baby is for use at home and to promote overall oral hygiene by cleaning your teeth and gums only.
2025-05-27
ISSA 4 Smile - ISSA 4 Smile is for use at home and to promote overall oral hygiene by cleaning your teeth and gums only.
2025-05-27
ISSA 4 Smile - ISSA 4 Smile is for use at home and to promote overall oral hygiene by cleaning your teeth and gums only.
2025-05-27
ISSA 4 Smile - ISSA 4 Smile is for use at home and to promote overall oral hygiene by cleaning your teeth and gums only.
2025-05-27
ISSA 4 - ISSA 4 is for use at home and to promote overall oral hygiene by cleaning your teeth and gums only.
2025-05-27
ISSA 4 - ISSA 4 is for use at home and to promote overall oral hygiene by cleaning your teeth and gums only.
2025-05-27
ISSA 4 - ISSA 4 is for use at home and to promote overall oral hygiene by cleaning your teeth and gums only.
2025-05-27
ISSA 4 Plus - ISSA 4 Plus is for use at home and to promote overall oral hygiene by cleaning your teeth and gums only.
2025-05-27
ISSA 4 Plus - ISSA 4 Plus is for use at home and to promote overall oral hygiene by cleaning your teeth and gums only.
2025-05-27
FAQ 302 - FAQ 302 is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila-V and females with androgenetic alopecia who have Ludwig-Savin Classifications of l-II and Fitzpatrick Classification of Skin Phototypes I to IV.
2024-12-19
Luna 4 Plus - Luna 4 plus is a Near-Infrared Heated Cleansing Device With Red LED light & Microcurrent MassageMicrocurrent: indicated for facial stimulationRED+IR: indicated for treat periorbital wrinkle
2024-09-26
Luna 4 Plus - Luna 4 plus is a Near-Infrared Heated Cleansing Device With Red LED light & Microcurrent MassageMicrocurrent: indicated for facial stimulationRED+IR: indicated for treat periorbital wrinkle
2024-09-26
PEACH 2 pro max - PEACH 2 pro max is an over-the-counter device intended for the removal of unwanted body hair and/or facial hair.
2024-08-08
PEACH 2 go - PEACH 2 go is an over-the-counter device intended for the removal of unwanted body hair and/or facial hair.
2024-03-01
PEACH 2 go - PEACH™ 2 go is an over-the-counter device intended for the removal of unwanted body hair and/or facial hair.
2024-08-07
PEACH 2 go - PEACH™ 2 go is an over-the-counter device intended for the removal of unwanted body hair and/or facial hair.
2024-08-07
ESPADA 2 - The ESPADA 2 Acne-Clearing Blue Light Pen is intended for use as an at-home device for the treatment of mild to moderate inflammatory acne.
2024-08-06
ESPADA 2 - The ESPADA 2 Acne-Clearing Blue Light Pen is intended for use as an at-home device for the treatment of mild to moderate inflammatory acne.
2024-08-06
ESPADA 2 - The ESPADA 2 Acne-Clearing Blue Light Pen is intended for use as an at-home device for the treatment of mild to moderate inflammatory acne.
2024-08-06
BEAR 2 Body - Bear 2 body is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.
2024-05-16
BEAR 2 Body - Bear 2 body is intended for body skin stimulation and is indicated for over-the-counter cosmetic use.
2024-05-16
FAQ 202 - FAQ™ 202 is intended to use LED light for the treatment of wrinkles and mild to moderate acne.
2024-04-24