510(k) · Cleared
ClearedGold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fci (France Chirurgie Instrumentation) Sas · NCB Weights, Eyelid, Implantable
Cleared on Jun 11, 2021 as substantially equivalent to K150986 (Meddev Corporation, 2015) after a 186-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Jun 11, 2021
- Review
- 186 days
- Class
- Class II
- Product code
- NCB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K983607 (1999). No later device cites it as a predicate yet.
- Root · 3 generations backK983607 Labtician Lid Load Gold Eyelid Weight ImplantsLabtician Ophthalmics, Inc. · 1999
- 2 generations backK011740 Contour Design Gold Eyelid Implant, Model Contour Design (Series 3000)Meddev Corp. · 2001
- 1 generation backK150986 Contour Eyelid Weight Implants, ThinProfile Eyelid Weight ImplantsMeddev Corporation · 2015 · Recalled
- This deviceK203569 Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid…Fci (France Chirurgie Instrumentation) Sas · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K983607 | Labtician Lid Load Gold Eyelid Weight Implants | Labtician Ophthalmics, Inc. | 1999 | — |
| −2 | K011740 | Contour Design Gold Eyelid Implant, Model Contour Design (Series 3000) | Meddev Corp. | 2001 | — |
| −1 | K150986 | Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants | Meddev Corporation | 2015 | 2 |
| 0 (this device) | K203569 | Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants | Fci (France Chirurgie Instrumentation) Sas | 2021 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NCB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K150986 | Contour Eyelid Weight Implants, ThinProfile Eyelid Weight ImplantsSummary page 4…yelid Implants are substantially equivalent to the Contour™ and ThinProfile™ Eyelid Weight Implants marketed by MedDev Corporation, 510(k) Premarket Notification Number: K150986, FDA Classification Product Code MML. The following are included as reference devices for the purpose of sterilization and bioco… | 2015 |
| † | K011740 | Contour Design Gold Eyelid Implant, Model Contour Design (Series 3000) | 2001 |
| † | K983607 | Labtician Lid Load Gold Eyelid Weight Implants | 1999 |
| † | K000127 | Kurz Pure Gold Upper Eyelids Implant (Oberascher), Model 4001 02-4001 10 | 2000 |
| † | K170591 | Altomed Malhotra Platinum Segments | 2017 |
| † | K011115 | Kurz Upper Eyelid Implant- Platinum/Iridium,Models Regular 4007 003-007, Special 4007… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All NCB devicesNCB Weights, Eyelid, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · NCB
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · NCB
Too few NCB 510(k)s in any year since 2007 to give a median.
Recalls per year · NCB
No recall names NCB since 2007.
Adverse event reports per year · NCB
No MAUDE report names NCB since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Gold and Platinum Tapered Weight Eyelid Implants are intended for the gravity-assisted treatment of protracted or permanent lagophthalmos, usually resulting from facial paralysis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203569 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203569: Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203569
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026