Clearance Summary
CRYSTALSERT CRYSTALENS DELIVERY SYSTEM received FDA 510(k) clearance under submission number K082944, 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 2008-10-16.
- Submission: K082944
- Applicant / Sponsor: Bausch & Lomb, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4300
- Decision date: 2008-10-16
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.