Clearance Summary
Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner received FDA 510(k) clearance under submission number K181627, sponsored by Bausch & Lomb, Incorporated. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2018-08-10.
- Submission: K181627
- Applicant / Sponsor: Bausch & Lomb, Incorporated
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5918
- Decision date: 2018-08-10
Classification & Regulation
This clearance is catalogued under FDA product code MRC and 21 CFR 886.5918, within the Ophthalmic review panel as a Class II device.