Clearance Summary
ABT12 multi-purpose solution received FDA 510(k) clearance under submission number K202932, 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 2021-05-28.
- Submission: K202932
- Applicant / Sponsor: Bausch & Lomb, Incorporated
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5928
- Decision date: 2021-05-28
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.