510(k) · Cleared
ClearedLightStim Elipsa
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 Jan 26, 2022 as substantially equivalent to K203214 (Shenzhen Kaiyan Medical CO, Ltd., 2021) and 2 other predicates after a 148-day review. Its family tree reaches back 15 generations to 1995. 1 later device descends from it.
- Decided
- Jan 26, 2022
- Review
- 148 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K943450 (1995). 123 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations between
- 3 generations backK180447 reVive Light Therapy LED Cleansing SystemLed Technologies, Inc. · 2018
- 2 generations backK183118 dpl SpotLiteLed Technologies, Inc. · 2019
- 1 generation backK203214 DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd. · 2021
- This deviceK212771 LightStim ElipsaLed Intellectual Properties, LLC · 2022
- Descendant · cites it directly · 0 of its ownK261473 ChromixTermosalud S.L. · 2026
Show all 15 generations
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 10 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 9 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 8 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 7 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 6 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 5 generations backK121435 Silkn BlueHome Skinovations, Ltd. · 2013
- 4 generations backK153081 Clear Bi-LightMichael Todd, LP · 2016
- 3 generations backK180447 reVive Light Therapy LED Cleansing SystemLed Technologies, Inc. · 2018
- 2 generations backK183118 dpl SpotLiteLed Technologies, Inc. · 2019
- 1 generation backK203214 DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd. · 2021
- This deviceK212771 LightStim ElipsaLed Intellectual Properties, LLC · 2022
Most influential descendants
Showing 1 of 1 · See all- K261473ChromixTermosalud S.L. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −14 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −10 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −9 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −8 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −7 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −6 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| −5 | K121435 | Silkn Blue | Home Skinovations, Ltd. | 2013 | — |
| −4 | K153081 | Clear Bi-Light | Michael Todd, LP | 2016 | — |
| −3 | K180447 | reVive Light Therapy LED Cleansing System | Led Technologies, Inc. | 2018 | — |
| −2 | K183118 | dpl SpotLite | Led Technologies, Inc. | 2019 | — |
| −1 | K203214 | DemarkQ WOW, DemarkQ POP | Shenzhen Kaiyan Medical CO, Ltd. | 2021 | — |
| 0 (this device) | K212771 | LightStim Elipsa | Led Intellectual Properties, LLC | 2022 | — |
| +1 | K261473 | Chromix | Termosalud S.L. | 2026 | — |
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 | 11 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 7 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (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 |
|---|---|---|---|
| * | K203214 | DemarkQ WOW, DemarkQ POPSummary page 4…or Usual Name: Light-Based over-the-counter wrinkle reduction and acne treatment. Regulatory Class: II 3. Predicate Devices SHENZHEN KAIYAN MEDICAL CO LTD, DemarkQ (K203214) Medtek Skincare, LLC, Poly Clear (K183708) LED Intellectual Properties, LLC, LightStim Professional 2-Panel Light (K150098) 4.… | 2021 |
| * | K183708 | Poly ClearSummary page 4…wrinkle reduction and acne treatment. Regulatory Class: II 3. Predicate Devices SHENZHEN KAIYAN MEDICAL CO LTD, DemarkQ (K203214) Medtek Skincare, LLC, Poly Clear (K183708) LED Intellectual Properties, LLC, LightStim Professional 2-Panel Light (K150098) 4. Device Description The LightStim Elipsa i… | 2019 |
| * | K150098 | LightStim Professional 2-Panel LightSummary page 4…ces SHENZHEN KAIYAN MEDICAL CO LTD, DemarkQ (K203214) Medtek Skincare, LLC, Poly Clear (K183708) LED Intellectual Properties, LLC, LightStim Professional 2-Panel Light (K150098) 4. Device Description The LightStim Elipsa is an over-the-counter light emitting diode (LED) device that emits energy for use… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261473 | Chromix | 2026 | 0 |
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 27 years and passes through 10 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 123 ancestors have a recall of any class.
- Of its descendants, K261473 (Termosalud S.L., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K203214.
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 LightStim Elipsa is a LED light therapy device which uses specific wavelengths of light, produced by light emitting diodes (LEDs). It is intended to emit energy in the red and infrared region of the light spectrum to provide treatment for full face wrinkles. The blue and red light spectrum is intended for the treatment of mild to moderate inflammatory 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/K212771 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212771: LightStim Elipsa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212771
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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