Clearance Summary
PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System received FDA 510(k) clearance under submission number K170409, sponsored by Topcon Medical Laser Systems, Inc. (Tmls). 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 2017-09-12.
- Submission: K170409
- Applicant / Sponsor: Topcon Medical Laser Systems, Inc. (Tmls)
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2017-09-12
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.