510(k) · Cleared
ClearedLightstim for Acne/ Lightstim for Acne Mini
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Led Intellectual Properties, LLC · OLP Over-The-Counter Powered Light Based Laser For Acne
Cleared on Jan 6, 2014 as substantially equivalent to K093963 (Silver Bay, LLC, 2010) and 2 other predicates after a 231-day review. Its family tree reaches back 11 generations to 1995. 81 later devices descend from it.
- Decided
- Jan 6, 2014
- Review
- 231 days
- Class
- Class II
- Product code
- OLP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K943450 (1995). 97 ancestors in all, the oldest K800617 (1980). 81 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 7 generations between
- 3 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 2 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 1 generation backK121435 Silkn BlueHome Skinovations, Ltd. · 2013
- This deviceK131461 Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC · 2014
- Descendant · cites it directly · 55 of its ownK142246 LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC · 2015
- Descendant · cites it directly · 52 of its ownK172555 Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity · 2018
- Descendant · 2 generations on · 50 of its ownK160691 Acne Light Therapy WandZuko, Inc. · 2016
- Descendant · 2 generations on · 46 of its ownK192295 PDT-FaceBeijing Adss Development Co., Ltd. · 2020
- Descendant · 3 generations on · 39 of its ownK202390 Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd. · 2021
Show all 11 generations
- Root · 11 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 9 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 8 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 7 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 6 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 5 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 4 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 3 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 2 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 1 generation backK121435 Silkn BlueHome Skinovations, Ltd. · 2013
- This deviceK131461 Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC · 2014
Showing 5 of 81 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 81 · See all- K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC · 2015 · cites it directly55descendants
- K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity · 2018 · cites it directly52descendants
- K160691Acne Light Therapy WandZuko, Inc. · 2016 · 2 generations on50descendants
- K192295PDT-FaceBeijing Adss Development Co., Ltd. · 2020 · 2 generations on46descendants
- K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd. · 2021 · 3 generations on39descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −10 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −9 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −8 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −7 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −6 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −5 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −4 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −3 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −2 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| −1 | K121435 | Silkn Blue | Home Skinovations, Ltd. | 2013 | — |
| 0 (this device) | K131461 | Lightstim for Acne/ Lightstim for Acne Mini | Led Intellectual Properties, LLC | 2014 | — |
| +1 | K142246 | LightStim for Acne/ LightStim for Acne Mini | Led Intellectual Properties, LLC | 2015 | — |
| +1 | K172555 | Sapphire, Elevare Sapphire | Omm Imports, Inc. D/B/A Zero Gravity | 2018 | — |
| +2 | K160691 | Acne Light Therapy Wand | Zuko, Inc. | 2016 | — |
| +2 | K192295 | PDT-Face | Beijing Adss Development Co., Ltd. | 2020 | — |
| +3 | K202390 | Aduro Light Beauty Mask | Shenzhen Kaiyan Medical CO, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 8 | 0 |
| 1995 | 9 | 0 |
| 1996 | 12 | 0 |
| 1997 | 13 | 0 |
| 1998 | 9 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 6 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 34 | 0 |
| 2026 | 13 | 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 OLP? 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 OLP device
- #1 K214103 Shani Darden LED light therapy maskscore 25.5 · 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? (3)
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 |
|---|---|---|---|
| * | K093963 | Quasar Blue Light Therapy SystemSummary page 2…16 Page 2 of 3 3. Predicate. Devices Quasar Blue Light Therapy System (K093963),Tanda Skincare (K08059.l), Silkn Blue (121435) 4. Devic Description LightStirn for Acne Mini, model: LS4AM is a hand-held d… | 2010 |
| * | K080591 | Tanda Skincare System, Model: PtscsSummary page 2…al Properties, LLC believes that LightStim. for Acne Mini has shown substantial equivalence to the predicate devices. Quasar Blue Light System (K093964). Tanda Skincare (K080591), Silkn Blue (121436). v Page 3 of 3 i —- i Device Comparrison Table i ) Tanda Shincaro Gutan Be Lgn Thermy… | 2008 |
| * | K121435 | Silkn BlueSummary page 2…Page 2 of 3 3. Predicate. Devices Quasar Blue Light Therapy System (K093963),Tanda Skincare (K08059.l), Silkn Blue (121435) 4. Devic Description LightStirn for Acne Mini, model: LS4AM is a hand-held device consisting of low intens ity light emitting… | 2013 |
What descends from it? (81)
See all 813 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 19 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 3 of the 97 ancestors have a recall of any class.
- Of its descendants, K142246 (Led Intellectual Properties, LLC, 2015) has gone furthest, with 55 descendants of its own.
- 3 other devices also cite its predicate K093963.
How does its category compare?
All OLP devicesOLP Over-The-Counter Powered Light Based Laser For Acne: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · OLP
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLP
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLP
4in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OLP
1in 2025
MAUDE reports naming product code OLP, 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 | 1 | — | 0 | 0 |
| 2010 | 3 | 247 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 3 | 245 | 0 | 0 |
| 2014 | 3 | 255 | 0 | 1 |
| 2015 | 3 | 159 | 0 | 0 |
| 2016 | 6 | 99 | 0 | 1 |
| 2017 | 4 | 151 | 4 | 1 |
| 2018 | 5 | 104 | 0 | 7 |
| 2019 | 2 | — | 0 | 19 |
| 2020 | 1 | — | 0 | 8 |
| 2021 | 6 | 260 | 0 | 7 |
| 2022 | 5 | 245 | 0 | 1 |
| 2023 | 3 | 109 | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 3 | 88 | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
LightStim for Acne Mini is an over-the-counter hand-held device intended for the use in the treatment of mild to moderate acne.
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/K131461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131461: Lightstim for Acne/ Lightstim for Acne Mini.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131461
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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