510(k) · Cleared
ClearedLightStim Professional 2-Panel Light
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 Apr 9, 2015 as substantially equivalent to K092800 (Led Intellectual Properties, LLC, 2010) and 2 other predicates after a 79-day review. Its family tree reaches back 12 generations to 1995. 10 later devices descend from it.
- Decided
- Apr 9, 2015
- Review
- 79 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K943450 (1995). 101 ancestors in all, the oldest K800617 (1980). 10 later devices descend from it, 5 citing it directly.
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 8 generations between
- 3 generations backK050216 Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited · 2005
- 2 generations backK072459 Omnilux New-UPhoto Therapeutics, Inc. · 2008
- 1 generation backK092800 Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC · 2010
- This deviceK150098 LightStim Professional 2-Panel LightLed Intellectual Properties, LLC · 2015
- Descendant · cites it directly · 4 of its ownK151333 LightStim for Pain LED BeltLed Intellectual Properties, LLC · 2015
- Descendant · cites it directly · 3 of its ownK153399 LightStim Professional LED BedLed Intellectual Properties, LLC · 2016
- Descendant · cites it directly · 1 of its ownK260129 Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026
- Descendant · 2 generations on · 1 of its ownK241947 EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
- Descendant · cites it directly · 1 of its ownK212771 LightStim ElipsaLed Intellectual Properties, LLC · 2022
Show all 12 generations
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 10 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 9 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 8 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 7 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 6 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 5 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 4 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 3 generations backK050216 Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited · 2005
- 2 generations backK072459 Omnilux New-UPhoto Therapeutics, Inc. · 2008
- 1 generation backK092800 Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC · 2010
- This deviceK150098 LightStim Professional 2-Panel LightLed Intellectual Properties, LLC · 2015
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC · 2015 · cites it directly4descendants
- K153399LightStim Professional LED BedLed Intellectual Properties, LLC · 2016 · cites it directly3descendants
- K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026 · cites it directly1descendant
- K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025 · 2 generations on1descendant
- K212771LightStim ElipsaLed Intellectual Properties, LLC · 2022 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −11 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −10 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −9 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −8 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −7 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −6 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −5 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −4 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −3 | K050216 | Omnilux Revive and Omnilux Plus | Photo Therapeutics Limited | 2005 | — |
| −2 | K072459 | Omnilux New-U | Photo Therapeutics, Inc. | 2008 | — |
| −1 | K092800 | Anti-Wrinkle (Aging) Light, Model Aal | Led Intellectual Properties, LLC | 2010 | — |
| 0 (this device) | K150098 | LightStim Professional 2-Panel Light | Led Intellectual Properties, LLC | 2015 | — |
| +1 | K151333 | LightStim for Pain LED Belt | Led Intellectual Properties, LLC | 2015 | — |
| +1 | K153399 | LightStim Professional LED Bed | Led Intellectual Properties, LLC | 2016 | — |
| +1 | K260129 | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026 | — |
| +2 | K241947 | EnergyLounger (TY-01) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025 | — |
| +1 | K212771 | LightStim Elipsa | Led Intellectual Properties, LLC | 2022 | — |
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 | 10 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K092800 | Anti-Wrinkle (Aging) Light, Model AalSummary page 4…System Classification Code and name: OHS – Light Based OTC Wrinkles and ILY – Therapeutic Heating 3. Predicate Devices LED Intellectual Properties Light for Wrinkles (K092800) + LightStim for Wrinkles (K120775) + Pain Therapy Light (K083580) 4. Device Description The LightStim Professional 2-Panel Lig… | 2010 |
| * | K120775 | Light for WrinklesSummary page 4…e: OHS – Light Based OTC Wrinkles and ILY – Therapeutic Heating 3. Predicate Devices LED Intellectual Properties Light for Wrinkles (K092800) + LightStim for Wrinkles (K120775) + Pain Therapy Light (K083580) 4. Device Description The LightStim Professional 2-Panel Light System is a portable device that… | 2012 |
| * | K083580 | Anti-Wrinkle Light, Model 1302 and Pain Therapy Light, Model 1301Summary page 4…es and ILY – Therapeutic Heating 3. Predicate Devices LED Intellectual Properties Light for Wrinkles (K092800) + LightStim for Wrinkles (K120775) + Pain Therapy Light (K083580) 4. Device Description The LightStim Professional 2-Panel Light System is a portable device that has two (2) separate interchan… | 2009 |
What descends from it? (10)
5 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 20 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 101 ancestors have a recall of any class.
- Of its descendants, K151333 (Led Intellectual Properties, LLC, 2015) has gone furthest, with 4 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. 2015, 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 Professional 2-Panel Light System has two (2) interchangeable 2-Panel LED Systems, each mounted on a hands-free, fully articulating arms:
System #1- emitting energy in the visible and IR spectrums intended for use in the treatment of full-face wrinkles.
System #2 - emitting energy in the visible and IR spectrum intended to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and the temporary relaxation of muscles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150098 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150098: LightStim Professional 2-Panel Light.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150098
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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