Clearance Summary
OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION received FDA 510(k) clearance under submission number K112909, sponsored by Bausch & Lomb, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2012-04-30.
- Submission: K112909
- Applicant / Sponsor: Bausch & Lomb, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5928
- Decision date: 2012-04-30
Classification & Regulation
This clearance is catalogued under FDA product code LPN and 21 CFR 886.5928, within the Ophthalmic review panel as a Class II device.