510(k) · Cleared
ClearedLightstim Anti-Wrinkle Otc Model Aal Otc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Led Intellectual Properties, LLC · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Jul 1, 2010 after a 64-day review. The FDA summary names its predicate without a number. 170 later devices descend from it.
- Decided
- Jul 1, 2010
- Review
- 64 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 0
170 later devices descend from it, 4 citing it directly.
- This deviceK101190 Lightstim Anti-Wrinkle Otc Model Aal OtcLed Intellectual Properties, LLC · 2010
- Descendant · cites it directly · 150 of its ownK120775 Light for WrinklesLed Intellectual Properties, LLC · 2012
- Descendant · 2 generations on · 107 of its ownK140471 Pro X Otc 5La Lumiere, LLC · 2015
- Descendant · 3 generations on · 106 of its ownK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
- Descendant · 2 generations on · 105 of its ownK133896 Rejuvalite MDTrophy Skin, Inc. · 2014
- Descendant · 3 generations on · 93 of its ownK170984 LG Beauty Led MaskLg Electronics · 2017
Showing 5 of 170 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 170 · See all- K120775Light for WrinklesLed Intellectual Properties, LLC · 2012 · cites it directly150descendants
- K140471Pro X Otc 5La Lumiere, LLC · 2015 · 2 generations on107descendants
- K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017 · 3 generations on106descendants
- K133896Rejuvalite MDTrophy Skin, Inc. · 2014 · 2 generations on105descendants
- K170984LG Beauty Led MaskLg Electronics · 2017 · 3 generations on93descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K101190 | Lightstim Anti-Wrinkle Otc Model Aal Otc | Led Intellectual Properties, LLC | 2010 | — |
| +1 | K120775 | Light for Wrinkles | Led Intellectual Properties, LLC | 2012 | — |
| +2 | K140471 | Pro X Otc 5 | La Lumiere, LLC | 2015 | — |
| +3 | K163329 | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 | Pulsaderm, LLC | 2017 | — |
| +2 | K133896 | Rejuvalite MD | Trophy Skin, Inc. | 2014 | — |
| +3 | K170984 | LG Beauty Led Mask | Lg Electronics | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 6 | 0 |
| 2016 | 1 | 0 |
| 2017 | 9 | 0 |
| 2018 | 7 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 11 | 0 |
| 2022 | 18 | 0 |
| 2023 | 14 | 0 |
| 2024 | 16 | 0 |
| 2025 | 48 | 0 |
| 2026 | 27 | 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? (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 |
|---|---|---|---|
| * | — | LED Intellectual Properties, LLC - Anti-Wrinkle Light, Model AAL Named without a submission number |
What descends from it? (170)
See all 1704 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?
- Of its descendants, K120775 (Led Intellectual Properties, LLC, 2012) has gone furthest, with 150 descendants of its own.
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. 2010, 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 Light for Winkles is an Over-The-Counter handheld device intended for use in the treatment of periorbital wrinkles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101190 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101190: Lightstim Anti-Wrinkle Otc Model Aal Otc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101190
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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