Clearance Summary
Stellaris Elite Vision Enhancement System received FDA 510(k) clearance under submission number K162342, sponsored by Bausch+Lomb. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2017-03-24.
- Submission: K162342
- Applicant / Sponsor: Bausch+Lomb
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4670
- Decision date: 2017-03-24
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.