Clearance Summary
Onycho Laser V received FDA 510(k) clearance under submission number K241116, sponsored by Terasysd&C, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2024-07-22.
- Submission: K241116
- Applicant / Sponsor: Terasysd&C, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2024-07-22
Classification & Regulation
This clearance is catalogued under FDA product code PDZ and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.