Clearance Summary
LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS received FDA 510(k) clearance under submission number K983607, sponsored by Labtician Ophthalmics, 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 1999-01-08.
- Submission: K983607
- Applicant / Sponsor: Labtician Ophthalmics, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5700
- Decision date: 1999-01-08
Classification & Regulation
This clearance is catalogued under FDA product code MML and 21 CFR 886.5700, within the Ophthalmic review panel as a Class II device.