Clearance Summary
PRECISION UV(TM) (VASURFILCON A) received FDA 510(k) clearance under submission number K944722, 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 1994-10-03.
- Submission: K944722
- Applicant / Sponsor: Pilkington Barnes-Hind, Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5925
- Decision date: 1994-10-03
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.