Clearance Summary
LENSTAR, MODEL LS900 received FDA 510(k) clearance under submission number K082891, sponsored by Haag-Streit AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2009-10-20.
- Submission: K082891
- Applicant / Sponsor: Haag-Streit AG
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1850
- Decision date: 2009-10-20
Classification & Regulation
This clearance is catalogued under FDA product code HJO and 21 CFR 886.1850, within the Ophthalmic review panel as a Class II device.