510(k) K252198

Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) by Medical Brands Laboratories B.V. — Product Code GEH

K252198 is an FDA 510(k) premarket notification submitted by Medical Brands Laboratories B.V. for the device "Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)". The FDA issued a decision of Substantially Equivalent on April 2, 2026. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Medical Brands Laboratories B.V. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2026
Date Received
July 14, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryosurgical, Accessories
Device Class
Class II
Regulation Number
878.4350
Review Panel
SU
Submission Type