K251524 is an FDA 510(k) clearance for the Dr. Yglo Skin Tag Remover, a Unit, Cryosurgical, Accessories (Class II — Special Controls, product code GEH), submitted by Theotclab Healthcare B.V. (Amsterdam, NL). The FDA issued a Cleared decision on January 12, 2026, 241 days after receiving the submission on May 16, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4350.
| 510(k) Number | K251524 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 16, 2025 |
| Decision Date | January 12, 2026 |
| Days to Decision | 241 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GEH — Unit, Cryosurgical, Accessories |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4350 |