Clearance Summary
TETRAFILCON A received FDA 510(k) clearance under submission number K990606, sponsored by CooperVision, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1999-03-15.
- Submission: K990606
- Applicant / Sponsor: CooperVision, Inc.
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5925
- Decision date: 1999-03-15
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.