Clearance Summary
SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS CLEANER, VISONIC DOME, LENSONIC CONTACT received FDA 510(k) clearance under submission number K974724, sponsored by Lens Comfort, 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 1998-03-02.
- Submission: K974724
- Applicant / Sponsor: Lens Comfort, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5928
- Decision date: 1998-03-02
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.