510(k) K252198
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