Clearance Summary
ML EYE SPEAR, MODEL ML 27 ES received FDA 510(k) clearance under submission number K002279, 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 2000-08-18.
- Submission: K002279
- Applicant / Sponsor: Med-Logics, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4790
- Decision date: 2000-08-18
Classification & Regulation
This clearance is catalogued under FDA product code HOZ and 21 CFR 886.4790, within the Ophthalmic review panel as a Class II device.