Clearance Summary
BLADE GAUGE received FDA 510(k) clearance under submission number K812011, sponsored by Koi, 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 1981-07-28.
- Submission: K812011
- Applicant / Sponsor: Koi, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4350
- Decision date: 1981-07-28
Classification & Regulation
This clearance is catalogued under FDA product code HOE and 21 CFR 886.4350, within the Ophthalmic review panel as a Class I device.