Clearance Summary
BAUSCH & LOMB INJECTOR SYSTEM received FDA 510(k) clearance under submission number K131958, 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 2014-01-09.
- Submission: K131958
- Applicant / Sponsor: Bausch & Lomb
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4300
- Decision date: 2014-01-09
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.