Clearance Summary
PHACOLASE ER: YAG LASER received FDA 510(k) clearance under submission number K991993, sponsored by Aesculap-Meditec GmbH. 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 1999-11-17.
- Submission: K991993
- Applicant / Sponsor: Aesculap-Meditec GmbH
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 1999-11-17
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.