510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203569Substantially Equivalent

Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants

Fci (France Chirurgie Instrumentation) SAS, Paris, FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203569 is the FDA 510(k) clearance record for Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants, a class II device, cleared for Fci (France Chirurgie Instrumentation) Sas on under FDA product code NCB (Weights, Eyelid, Implantable). FDA's definition for product code NCB reads: "Gravity assisted treatment of lagophthalmos (incomplete eyelid closure)". FDA records list 4 510(k) clearances for Fci (France Chirurgie Instrumentation) Sas, from to . As of , FDA records show no recalls naming K203569.

Clearance record

Decision date
Received
(186 days to decision)
Product code
NCB Weights, Eyelid, Implantable
Regulation
21 CFR 886.5700
Device class
Class II
Review panel
Ophthalmic
Applicant
Fci (France Chirurgie Instrumentation) Sas 20-22 Rue Louis Armand, Paris, FR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NCB

Trailing 12 months

FDA records hold no clearances under product code NCB in the trailing twelve months.

FDA records show no clearances under product code NCB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NCB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260