510(k) · Cleared
Recalled · Class II · 2024Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meddev Corporation · MML Weights, Eyelid, External
Cleared on Aug 17, 2015 as substantially equivalent to K011740 (Meddev Corp., 2001) after a 125-day review. Its family tree reaches back 2 generations to 1999. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Aug 17, 2015
- Review
- 125 days
- Class
- Class II
- Product code
- MML
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to K983607 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK983607 Labtician Lid Load Gold Eyelid Weight ImplantsLabtician Ophthalmics, Inc. · 1999
- 1 generation backK011740 Contour Design Gold Eyelid Implant, Model Contour Design (Series 3000)Meddev Corp. · 2001
- This deviceK150986 Contour Eyelid Weight Implants, ThinProfile Eyelid Weight ImplantsMeddev Corporation · 2015
- Descendant · cites it directly · 0 of its ownK203569 Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid…Fci (France Chirurgie Instrumentation) Sas · 2021
Most influential descendants
Showing 1 of 1 · See all- K203569Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid ImplantsFci (France Chirurgie Instrumentation) Sas · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983607 | Labtician Lid Load Gold Eyelid Weight Implants | Labtician Ophthalmics, Inc. | 1999 | — |
| −1 | K011740 | Contour Design Gold Eyelid Implant, Model Contour Design (Series 3000) | Meddev Corp. | 2001 | — |
| 0 (this device) | K150986 | Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants | Meddev Corporation | 2015 | — |
| +1 | K203569 | Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants | Fci (France Chirurgie Instrumentation) Sas | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
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 MML? 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 |
|---|---|---|---|
| * | K011740 | Contour Design Gold Eyelid Implant, Model Contour Design (Series 3000)Summary page 4…nufacturer: MedDev Corp Predicate Device Common Name: Implantable Eyelid Weights Predicate Device Premarket Notification # K011740 Predicate Device Classification: 21 CFR 886.5700 Predicate Device Classification & Class II, Pro… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203569 | Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 12, 2024 | Class II | Z-1745-2025 | Process control | Due to mislabeling of products |
| Jul 12, 2024 | Class II | Z-1744-2025 | Process control | Due to mislabeling of products |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 14.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K203569 (Fci (France Chirurgie Instrumentation) Sas, 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MML devicesMML Weights, Eyelid, External: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · MML
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MML
Too few MML 510(k)s in any year since 2007 to give a median.
Recalls per year · MML
No recall names MML since 2007.
Adverse event reports per year · MML
1in 2022
MAUDE reports naming product code MML, not matched to any one device; reports are not rates.
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 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MedDev Contour and ThinProfile Eyelid Weight Implants are designed for the gravity-assisted treatment of
protracted or permanent lagophthalmos, usually resulting from facial paralysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150986 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150986: Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150986
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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