Clearance Summary
VISTAKON (GENFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILIITY TINT received FDA 510(k) clearance under submission number K964612, sponsored by Vistakon, Johnson & Johnson Vision Products, 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 1997-01-30.
- Submission: K964612
- Applicant / Sponsor: Vistakon, Johnson & Johnson Vision Products, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5925
- Decision date: 1997-01-30
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.