Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)— 510(k) K252198
Substantially EquivalentMedical Brands Laboratories B.V.
FDA 510(k) clearance K252198 for Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover), Substantially Equivalent on 2026-04-02. Applicant: Medical Brands Laboratories B.V.. Device class: 2.
Summary
Medical Brands Laboratories' Advanced Cryo Skin Tag Remover, also named Advanced Skin Tag Remover in the record, is filed under product code GEH (Unit, Cryosurgical, Accessories).
Class II, 21 CFR 878.4350. It came in as a Traditional 510(k), and General and Plastic Surgery is both the classification panel and the review panel.
Medical Brands Laboratories filed from Diemen, the Netherlands. Review took 262 calendar days (July 14, 2025 to April 2, 2026).
Clearance details
- Applicant
- Medical Brands Laboratories B.V.
- 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
- Traditional
- Location
- Diemen, NL
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 Medical Brands Laboratories B.V.
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.