Clearance Summary
KERAVISION VACUUM RING SYSTEM received FDA 510(k) clearance under submission number K984540, sponsored by Keravision, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1999-04-28.
- Submission: K984540
- Applicant / Sponsor: Keravision, Inc.
- Clearance pathway: Abbreviated
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4370
- Decision date: 1999-04-28
Classification & Regulation
This clearance is catalogued under FDA product code HNO and 21 CFR 886.4370, within the Ophthalmic review panel as a Class I device.