Clearance Summary
KERATOME SYSTEM, MODEL K3000 received FDA 510(k) clearance under submission number K984537, sponsored by Insight Technologies Instruments, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1999-05-14.
- Submission: K984537
- Applicant / Sponsor: Insight Technologies Instruments, LLC
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4370
- Decision date: 1999-05-14
Classification & Regulation
This clearance is catalogued under FDA product code HMY and 21 CFR 886.4370, within the Ophthalmic review panel as a Class I device.