510(k) K161296
- Device
- Cool Renewal
- Applicant
- COOL RENEWAL, LLC
- 510(k) number
- K161296
- Product code
- GEH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-07-06
- Date received
- 2016-05-09
- Regulation
- 878.4350
- Classification name
- Unit, Cryosurgical, Accessories
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- ASHLEY RAINS
- Address
- 2515 Eugenia Ave., Suite 103 Nashville TN US 37211 37211
FDA Registration Numbers
- 1222780
- 2024311
- 3008252257
- 3004087544
- 3015961134
- 3027153085
- 1216677
- 9613249
- 2937707
- 1047843
- 1930126
- 3010140265
- 3039443708
- 3003678543
- 3004608878
- 3014144368
- 3015177815
- 3001675293
- 3015733082
- 1056356
- 3011706110
- 3004753330
- 3008729892
- 3008812068
- 3016267994
- 1220477
- 3008797959
- 2511556
- 3014527929
- 3004416964
- 2124215
- 3013283620
- 1720747
- 3015351183
- 3008262715
- 2953359
- 1313700
- 1649518
- 3039443404
- 3012697079
- 3012187635
- 1038758
- 2518897
- 3015612252
- 3015967359
- 1450908
- 2134265
- 3013445151
- 3003418325
- 3005740500
- 2521453
- 9610614
- 3004215117
- 9616793
- 3033589330
- 3002808022
- 3009470597
- 1424263
- 1417592
- 1719513
- 1216795
- 3004099264
- 3009762450
- 3022626486
- 3015225571
- 1528319
- 1811755
- 3010242262
- 3011307964
- 3012913237
- 3015309643
- 3006950086
- 1450662
- 3011788769
- 3010543854
- 1721504
- 3015521867
- 1218813
- 3020164048
- 3030529508
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00860441000430 | COOL RENEWAL | COOL RENEWAL, LLC | 2017-03-31 |
| 00860441000423 | COOL RENEWAL | COOL RENEWAL, LLC | 2017-03-31 |
| 00860441000416 | COOL RENEWAL | COOL RENEWAL, LLC | 2017-03-31 |
| 00860441000409 | COOL RENEWAL | COOL RENEWAL, LLC | 2017-03-31 |
Other 510(k) Records For Product Code GEH
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253230 | ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe | Erbe Elektromedizin GmbH | 2026-04-22 |
| K252198 | Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) | Medical Brands Laboratories B.V. | 2026-04-02 |
| K260377 | XSense Cryoablation System with CryoProbes | IceCure Medical , Ltd. | 2026-02-24 |
| K251928 | CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) | Medinice S.A. | 2026-02-13 |
| K251524 | Dr. Yglo Skin Tag Remover | Theotclab Healthcare B.V. | 2026-01-12 |
| K250742 | Focused Cryotherapy System | Focused Cryo, Inc. | 2025-12-09 |
| K253114 | TargetCool (RM-DT02W) | Recensmedical, Inc. | 2025-10-16 |
| K253000 | CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. | 2025-10-16 |
| K253348 | TargetCool-e | Recensmedical, Inc. | 2025-10-15 |
| K252903 | Verruca-Freeze H Plus | Cryosurgery, Inc. | 2025-10-10 |
| K251493 | Skin Clinic Freeze Point for Warts and Skin Tags | Cryoconcepts LP | 2025-05-22 |
| K242932 | Skin Clinic Nitro Clear Wart Remover | Cryoconcepts LP | 2025-04-15 |
| K243487 | CryoFreeze Wart and Skin Tag Remover | Cryosurgery, Inc. | 2025-03-13 |
| K243042 | Co-Ablation System with Sterile Co-Ablation Probe | Hygea Medical Technology Co., Ltd. | 2025-01-29 |
| K242288 | Advanced Cryo Wart Remover | Medical Brands Laboratories B.V. | 2025-01-21 |
Legacy Summary
summary
FDA Review
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