Clearance Summary
LENSX 550 LASER SYSTEM. MODEL 550 received FDA 510(k) clearance under submission number K094052, sponsored by Lensx Lasers, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2010-04-23.
- Submission: K094052
- Applicant / Sponsor: Lensx Lasers, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4390
- Decision date: 2010-04-23
Classification & Regulation
This clearance is catalogued under FDA product code OOE and 21 CFR 886.4390, within the Ophthalmic review panel as a Class II device.