Clearance Summary
LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY received FDA 510(k) clearance under submission number K982115, sponsored by Rim-Wide Companies, 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 1999-01-13.
- Submission: K982115
- Applicant / Sponsor: Rim-Wide Companies, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5928
- Decision date: 1999-01-13
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.