510(k) K251524

Dr. Yglo Skin Tag Remover by Theotclab Healthcare B.V. — Product Code GEH

K251524 is an FDA 510(k) premarket notification submitted by Theotclab Healthcare B.V. for the device "Dr. Yglo Skin Tag Remover". The FDA issued a decision of Substantially Equivalent on January 12, 2026. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Theotclab Healthcare B.V. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2026
Date Received
May 16, 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