Clearance Summary
ML MICROKERATOME received FDA 510(k) clearance under submission number K981071, sponsored by Med-Logics, 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 1998-07-23.
- Submission: K981071
- Applicant / Sponsor: Med-Logics, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4370
- Decision date: 1998-07-23
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.