Clearance Summary
BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM received FDA 510(k) clearance under submission number K082473, sponsored by Bausch & Lomb, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2009-01-05.
- Submission: K082473
- Applicant / Sponsor: Bausch & Lomb, Inc.
- Clearance pathway: Abbreviated
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4670
- Decision date: 2009-01-05
Classification & Regulation
This clearance is catalogued under FDA product code HQC and 21 CFR 886.4670, within the Ophthalmic review panel as a Class II device.