# K203569: Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants

- Pathway: 510(k) (Traditional)
- Applicant: Fci (France Chirurgie Instrumentation) Sas
- Decided: Jun 11, 2021 after 186 days
- Product code: NCB (Weights, Eyelid, Implantable)
- Device class: 2
- Regulation: 21 CFR 886.5700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K983607 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150986: Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants, Meddev Corporation (2015) Summary page 4.

## Indications for use
Gold and Platinum Tapered Weight Eyelid Implants are intended for the gravity-assisted treatment of protracted or permanent lagophthalmos, usually resulting from facial paralysis.

Source page: https://510kreport.com/device/K203569
Methodology: https://510kreport.com/methodology