Clearance Summary
STELLARIS PC VISION ENHANCEMENT SYSTEM received FDA 510(k) clearance under submission number K133486, 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 2014-03-12.
- Submission: K133486
- Applicant / Sponsor: Bausch & Lomb
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4670
- Decision date: 2014-03-12
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.