Clearance Summary
PRECISION UV (VASURFILCON A) received FDA 510(k) clearance under submission number K961299, sponsored by Pilkington Barnes-Hind, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1996-10-01.
- Submission: K961299
- Applicant / Sponsor: Pilkington Barnes-Hind, Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5925
- Decision date: 1996-10-01
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.