Clearance Summary
SOFT MATE AUTOMATIC CONTACT LENS CLEANING UNIT received FDA 510(k) clearance under submission number K852386, sponsored by Barnes-Hind, 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 1985-09-04.
- Submission: K852386
- Applicant / Sponsor: Barnes-Hind, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5928
- Decision date: 1985-09-04
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.