Clearance Summary
AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 received FDA 510(k) clearance under submission number K063694, sponsored by Bausch & Lomb, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2007-03-07.
- Submission: K063694
- Applicant / Sponsor: Bausch & Lomb, Inc.
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4300
- Decision date: 2007-03-07
Classification & Regulation
This clearance is catalogued under FDA product code KYB and 21 CFR 886.4300, within the Ophthalmic review panel as a Class I device.