Clearance Summary
RESOLUTION 5X (SPHERICAL) AND ULTRA GEL 5X (TORIC)(HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS, (CLEAR & BLUE VISIBILITY received FDA 510(k) clearance under submission number K992589, sponsored by Opti-Centre Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1999-08-26.
- Submission: K992589
- Applicant / Sponsor: Opti-Centre Laboratories
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5925
- Decision date: 1999-08-26
Classification & Regulation
This clearance is catalogued under FDA product code LPL and 21 CFR 886.5925, within the Ophthalmic review panel as a Class II device.