Clearance Summary
Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants received FDA 510(k) clearance under submission number K203569, sponsored by Fci (France Chirurgie Instrumentation) Sas. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2021-06-11.
- Submission: K203569
- Applicant / Sponsor: Fci (France Chirurgie Instrumentation) Sas
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5700
- Decision date: 2021-06-11
Classification & Regulation
This clearance is catalogued under FDA product code NCB and 21 CFR 886.5700, within the Ophthalmic review panel as a Class II device.