Cleared Traditional

Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants

K203569 · Fci (France Chirurgie Instrumentation) Sas · Ophthalmic
Jun 2021
Decision
186d
Days
Class 2
Risk

About This 510(k) Submission

K203569 is an FDA 510(k) clearance for the Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants, a Weights, Eyelid, Implantable (Class II — Special Controls, product code NCB), submitted by Fci (France Chirurgie Instrumentation) Sas (Paris, FR). The FDA issued a Cleared decision on June 11, 2021, 186 days after receiving the submission on December 7, 2020. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5700.

Submission Details

510(k) Number K203569 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 2020
Decision Date June 11, 2021
Days to Decision 186 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code NCB — Weights, Eyelid, Implantable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5700
Definition Gravity Assisted Treatment Of Lagophthalmos (incomplete Eyelid Closure)