510(k) · Cleared
ClearedLYMA Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lyma Life, Ltd. · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Mar 18, 2022 as substantially equivalent to K120775 (Led Intellectual Properties, LLC, 2012) and 1 other predicate after a 364-day review. Its family tree reaches back 3 generations to 2010. 2 later devices descend from it.
- Decided
- Mar 18, 2022
- Review
- 364 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K101190 (2010). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK101190 Lightstim Anti-Wrinkle Otc Model Aal OtcLed Intellectual Properties, LLC · 2010
- 2 generations backK120775 Light for WrinklesLed Intellectual Properties, LLC · 2012
- 1 generation backK120560 Trinity Wrinkle RemoverCarol Cole Company · 2012
- This deviceK210823 LYMA LaserLyma Life, Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK243330 LYMA Laser PROLyma Life, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK233862 Nuna Lux (NUNL528)Premier North America, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K101190 | Lightstim Anti-Wrinkle Otc Model Aal Otc | Led Intellectual Properties, LLC | 2010 | — |
| −2 | K120775 | Light for Wrinkles | Led Intellectual Properties, LLC | 2012 | — |
| −1 | K120560 | Trinity Wrinkle Remover | Carol Cole Company | 2012 | — |
| 0 (this device) | K210823 | LYMA Laser | Lyma Life, Ltd. | 2022 | — |
| +1 | K243330 | LYMA Laser PRO | Lyma Life, Ltd. | 2025 | — |
| +1 | K233862 | Nuna Lux (NUNL528) | Premier North America, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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 OHS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OHS device
- #1 K223544 LED light therapy mask (FM-01, FM-02, FM-03)score 48.4 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K120775 | Light for WrinklesSummary page 4…The LYMA Laser is substantially equivalent to the following predicates: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate K120775 LightStim for Wrinkles / LED Intellectual Properties K120560 Trinity Wrinkle Remover / Caro… | 2012 |
| * | K120560 | Trinity Wrinkle RemoverSummary page 4…Predicate Device Name / Manufacturer Primary Predicate K120775 LightStim for Wrinkles / LED Intellectual Properties K120560 Trinity Wrinkle Remover / Carol Cole Company The predicate devices have not been subject to a design related recall.… | 2012 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K243330 (Lyma Life, Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 10 other devices also cite its predicate K120775.
How does its category compare?
All OHS devicesOHS Light Based Over The Counter Wrinkle Reduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · OHS
42in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OHS
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OHS
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OHS
34in 2025
MAUDE reports naming product code OHS, 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 | 2 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 176 | 0 | 0 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 4 | 310 | 0 | 1 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 5 | 168 | 0 | 1 |
| 2015 | 4 | 241 | 0 | 0 |
| 2016 | 3 | 191 | 0 | 0 |
| 2017 | 8 | 133 | 0 | 1 |
| 2018 | 7 | 84 | 0 | 1 |
| 2019 | 4 | 99 | 0 | 1 |
| 2020 | 2 | — | 0 | 2 |
| 2021 | 7 | 162 | 0 | 2 |
| 2022 | 16 | 129 | 0 | 2 |
| 2023 | 12 | 101 | 0 | 4 |
| 2024 | 16 | 87 | 0 | 5 |
| 2025 | 42 | 89 | 0 | 34 |
| 2026 | 26 | 88 | 0 | — |
What is it indicated for?
The LYMA Laser is an Over-the-Counter (OTC) light based device intended for the use in treating full-face wrinkles.
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/K210823 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210823: LYMA Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210823
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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