Clearance Summary
ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING received FDA 510(k) clearance under submission number K964222, sponsored by Paladin Medical, 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 1996-12-20.
- Submission: K964222
- Applicant / Sponsor: Paladin Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5928
- Decision date: 1996-12-20
Classification & Regulation
This clearance is catalogued under FDA product code LYL and 21 CFR 886.5928, within the Ophthalmic review panel as a Class II device.