Clearance Summary
Sentient Manufacturing Laser Fiber received FDA 510(k) clearance under submission number K213554, sponsored by Sentient Manufacturing , LLC. 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 2022-02-02.
- Submission: K213554
- Applicant / Sponsor: Sentient Manufacturing , LLC
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2022-02-02
Classification & Regulation
This clearance is catalogued under FDA product code GEX and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.