510(k) K210529
K210529 is an FDA 510(k) premarket notification submitted by Theotclab Healthcare B.V. for the device "Dr. Yglo Wart Remover". The FDA issued a decision of Substantially Equivalent on May 6, 2021. 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
- May 6, 2021
- Date Received
- February 23, 2021
- 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