Clearance Summary
BAUSCH + LUMB, VIS100 INJECTOR SYSTEM received FDA 510(k) clearance under submission number K133146, sponsored by Bausch & Lomb. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2014-01-03.
- Submission: K133146
- Applicant / Sponsor: Bausch & Lomb
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4300
- Decision date: 2014-01-03
Classification & Regulation
This clearance is catalogued under FDA product code MSS and 21 CFR 886.4300, within the Ophthalmic review panel as a Class I device.