FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Skin Clinic Freeze Point for Warts and Skin Tags
K Number: K251493
·
Decision May 22, 2025
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
261
Applicant Total
8
Review Days
7
Basic Information
- Device Name
- Skin Clinic Freeze Point for Warts and Skin Tags
- K Number
- K251493
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4350
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cryoconcepts LP
- Date Received
- May 15, 2025
- Decision Date
- May 22, 2025
- Product Code
- GEH
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEH), ordered by most recent decision date.
ERBECRYO 2 Cryosurgical Unit and Accessories
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
XSense Cryoablation System with CryoProbes
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Dr. Yglo Skin Tag Remover
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Cryoconcepts LP
| K Number | Device Name | ||
|---|---|---|---|
| K242932 | Skin Clinic Nitro Clear Wart Remover | Apr 15, 2025 | Substantially Equivalent |
| K242625 | Freeze Point & Private Label Versions | Oct 25, 2024 | Substantially Equivalent |
| K240106 | Histofreezer V | Jun 10, 2024 | Substantially Equivalent |
| K211099 | Freezen Clear Skin Clinic Warts & Tags | Jun 17, 2022 | Substantially Equivalent |
| K190407 | CryoLab | Apr 22, 2019 | Substantially Equivalent |
| K183601 | CryoTouch | Apr 18, 2019 | Substantially Equivalent |
| K172769 | CryOmega Flexx | Nov 30, 2017 | Substantially Equivalent |