Skin Clinic Freeze Point for Warts and Skin Tags— 510(k) K251493
Substantially EquivalentCryoconcepts LP
FDA 510(k) clearance K251493 for Skin Clinic Freeze Point for Warts and Skin Tags, Substantially Equivalent on 2025-05-22. Applicant: Cryoconcepts LP. Device class: 2.
Clearance details
- Applicant
- Cryoconcepts LP
- Product code
- Product code GEH
- Device class
- Class 2
- Regulation
- 21 CFR 878.4350
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Easton, PA, US
Recent devices under product code GEH
view all- K260520 — Skin Clinic Nitro Clear for Warts and Skin Tags
- K262420 — Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000)
- K261068 — Maverix Cryo Biopsy Probe (MCB1000); Maverix Cryo Cartridge (CC1000)
- K261806 — ERBECRYO 2 Cryosurgical Unit and Accessories
- K253230 — ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe
More clearances from Cryoconcepts LP
view allAdverse events under product code GEH
product code GEH- Death
- 25
- Injury
- 351
- Malfunction
- 901
- Total
- 1,277
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.