510(k) K251493

Skin Clinic Freeze Point for Warts and Skin Tags by Cryoconcepts LP — Product Code GEH

K251493 is an FDA 510(k) premarket notification submitted by Cryoconcepts LP for the device "Skin Clinic Freeze Point for Warts and Skin Tags". The FDA issued a decision of Substantially Equivalent on May 22, 2025. The device falls under product code GEH (Unit, Cryosurgical, Accessories), a Class II device regulated under 21 CFR 878.4350. Cryoconcepts LP has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2025
Date Received
May 15, 2025
Clearance Type
Special
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