Skin Clinic Freeze Point for Warts and Skin Tags— 510(k) K251493

Substantially Equivalent

Cryoconcepts 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.

Clearance details

Applicant: Cryoconcepts LP
Product code: Code GEH
Advisory panel: General, Plastic Surgery
Date received: 2025-05-15
Decision date: 2025-05-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Easton, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEH

product code GEH

Death: 25
Injury: 351
Malfunction: 901
Total: 1,277

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.