510(k) · Cleared
ClearedLabtician Lid Load Gold Eyelid Weight Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Labtician Ophthalmics, Inc. · MML Weights, Eyelid, External
Cleared on Jan 8, 1999 after an 86-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Jan 8, 1999
- Review
- 86 days
- Class
- Class II
- Product code
- MML
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK983607 Labtician Lid Load Gold Eyelid Weight ImplantsLabtician Ophthalmics, Inc. · 1999
- Descendant · cites it directly · 2 of its ownK011740 Contour Design Gold Eyelid Implant, Model Contour Design (Series 3000)Meddev Corp. · 2001
- Descendant · 2 generations on · 1 of its ownK150986 Contour Eyelid Weight Implants, ThinProfile Eyelid Weight ImplantsMeddev Corporation · 2015 · Recalled
- Descendant · 3 generations on · 0 of its ownK203569 Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid…Fci (France Chirurgie Instrumentation) Sas · 2021
Most influential descendants
Showing 3 of 3 · See all- K011740Contour Design Gold Eyelid Implant, Model Contour Design (Series 3000)Meddev Corp. · 2001 · cites it directly2descendants
- K150986Contour Eyelid Weight Implants, ThinProfile Eyelid Weight ImplantsMeddev Corporation · 2015 · 2 generations on1descendant
- K203569Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid ImplantsFci (France Chirurgie Instrumentation) Sas · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K150986 | Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants | Meddev Corporation | 2015 | 2 |
| +3 | 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 |
|---|---|---|
| 2001 | 1 | 0 |
| 2015 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | — | Series 3000 Gold Eyelid Implants Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011740 | Contour Design Gold Eyelid Implant, Model Contour Design (Series 3000) | 2001 | 2 |
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?
- Of its descendants, K011740 (Meddev Corp., 2001) has gone furthest, with 2 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.
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?
Labtician Lid Load Gold Eyelid Weight Implants, surgically implanted
in the upper eyelid, work by gravity to restore a functional blink
mechanism in the patient with lagophthalmos resulting from
temporary or permanent facial paralysis, specifically the orbicularis
oculi muscle. This paralysis may be the result of Bell’s palsy or from
surgical trauma to the facial nerve.
The patient with lagophthalmos is unable to close the eyelid
completely because of partial or complete paralysis to the facial
nerve. This paralysis may be the result of Bell's palsy or from surgical
trauma to the facial nerve. The condition of paralysis can be either
permanent or transient.
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/K983607 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983607: Labtician Lid Load Gold Eyelid Weight Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983607
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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