510(k) · Cleared
ClearedLabtician Lid Load External Eyelid Sizing Set
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 Apr 12, 1999 as substantially equivalent to K940974 (Meddev Corp., 1994) after a 77-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Apr 12, 1999
- Review
- 77 days
- Class
- Class II
- Product code
- MML
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K940974 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK940974 Eyeclose External Eyelid WeightsMeddev Corp. · 1994
- This deviceK990224 Labtician Lid Load External Eyelid Sizing SetLabtician Ophthalmics, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940974 | Eyeclose External Eyelid Weights | Meddev Corp. | 1994 | — |
| 0 (this device) | K990224 | Labtician Lid Load External Eyelid Sizing Set | Labtician Ophthalmics, Inc. | 1999 | — |
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 |
|---|---|---|---|
| * | K940974 | Eyeclose External Eyelid WeightsSummary page 1…d Load™ External Eyelid Sizing Weights Common Name: External Eyelid Sizing Weights Classification Name: None known Predicate Device: EyeClose External Eyelid Weights, K940974. Device Description: Labtician Lid Load External Eyelid Sizing Weights are spherically radiused strips of pure tantalum (99.5%)… | 1994 |
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?
- Its one ancestor has no recall.
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 External Eyelid Sizing Weights are used by the physician to determine the correct gold eyelid weight to be implanted in the treatment of lagophthalmos. Labtician Lid Load External Eyelid Sizing Weights are used by the physician who affixes a succession of external eyelid weights to the outer surface of the eyelid using until the proper eyelid closure is attained. Because the levator muscle seems to strengthen after the weight is added…
Read the full statement (138 words)
Labtician Lid Load External Eyelid Sizing Weights are used by the physician to determine the correct gold eyelid weight to be implanted in the treatment of lagophthalmos.
Labtician Lid Load External Eyelid Sizing Weights are used by the physician who affixes a succession of external eyelid weights to the outer surface of the eyelid using until the proper eyelid closure is attained. Because the levator muscle seems to strengthen after the weight is added, the optimal weight for implantation is ususally that which holds lid about 1.0 mm lower than the normal lid as the patient looks straight ahead.
The corresponding implantable gold eyelid weight is then prescribed for implantation.
Sizing weights are not designed to be implanted, and are provided non-stetile and are re-usable following cleaning with soap and water and/or alcohol and rinsing with tap water.
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/K990224 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990224: Labtician Lid Load External Eyelid Sizing Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990224
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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