510(k) clearance

Skin Clinic Nitro Clear for Warts and Skin Tags

FDA 510(k) source

510(k) number

K260520

Applicant

Cryoconcepts LP

Decision date

Oct 27, 2026

Date received

Feb 17, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

GEH

Device type

Unit, Cryosurgical, Accessories

Device class

Class II

Regulation

21 CFR 878.4350

Advisory committee

General, Plastic Surgery

Statement or summary

Statement

Third party

N

Location

Easton, PA, US