510(k) · Cleared
ClearedLED Phototherapy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Li-Tek Electronic Technology Corporation · OLP Over-The-Counter Powered Light Based Laser For Acne
Cleared on Jan 30, 2017 as substantially equivalent to K121435 (Home Skinovations, Ltd., 2013) and 2 other predicates after a 185-day review. Its family tree reaches back 13 generations to 1995. 75 later devices descend from it.
- Decided
- Jan 30, 2017
- Review
- 185 days
- Class
- Class II
- Product code
- OLP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K943450 (1995). 148 ancestors in all, the oldest K800617 (1980). 75 later devices descend from it, 5 citing it directly.
- Root · 13 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 9 generations between
- 3 generations backK060792 IllumimedPhotoactif, LLC · 2006
- 2 generations backK083183 Aklarus Phototherapy SystemHill Laboratories Co. · 2009
- 1 generation backK111286 Quasar CalypsoSilver Bay, LLC · 2012
- This deviceK162098 LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017
- Descendant · cites it directly · 58 of its ownK171821 2 Face / Face EvolutionHeat IN A Click · 2018
- Descendant · cites it directly · 46 of its ownK192295 PDT-FaceBeijing Adss Development Co., Ltd. · 2020
- Descendant · 2 generations on · 42 of its ownK212155 TheraFace LEDTheragun, Inc. · 2021
- Descendant · 3 generations on · 39 of its ownK223544 LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd. · 2023
- Descendant · 2 generations on · 39 of its ownK202390 Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd. · 2021
Show all 13 generations
- Root · 13 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 10 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 9 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 8 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 7 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 6 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 5 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 4 generations backK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
- 3 generations backK060792 IllumimedPhotoactif, LLC · 2006
- 2 generations backK083183 Aklarus Phototherapy SystemHill Laboratories Co. · 2009
- 1 generation backK111286 Quasar CalypsoSilver Bay, LLC · 2012
- This deviceK162098 LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017
Showing 5 of 75 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 75 · See all- K1718212 Face / Face EvolutionHeat IN A Click · 2018 · cites it directly58descendants
- K192295PDT-FaceBeijing Adss Development Co., Ltd. · 2020 · cites it directly46descendants
- K212155TheraFace LEDTheragun, Inc. · 2021 · 2 generations on42descendants
- K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd. · 2023 · 3 generations on39descendants
- K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd. · 2021 · 2 generations on39descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −12 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −10 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −9 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −8 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −7 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −6 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −5 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −4 | K042630 | Revlight Skin Care System | Skincare Technology, Inc. | 2005 | — |
| −3 | K060792 | Illumimed | Photoactif, LLC | 2006 | — |
| −2 | K083183 | Aklarus Phototherapy System | Hill Laboratories Co. | 2009 | — |
| −1 | K111286 | Quasar Calypso | Silver Bay, LLC | 2012 | — |
| 0 (this device) | K162098 | LED Phototherapy Device | Li-Tek Electronic Technology Corporation | 2017 | — |
| +1 | K171821 | 2 Face / Face Evolution | Heat IN A Click | 2018 | — |
| +1 | K192295 | PDT-Face | Beijing Adss Development Co., Ltd. | 2020 | — |
| +2 | K212155 | TheraFace LED | Theragun, Inc. | 2021 | — |
| +3 | K223544 | LED light therapy mask (FM-01, FM-02, FM-03) | Guangdong Newdermo Biotech Co., Ltd. | 2023 | — |
| +2 | 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 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 10 | 0 |
| 1996 | 12 | 0 |
| 1997 | 15 | 0 |
| 1998 | 12 | 0 |
| 1999 | 5 | 0 |
| 2000 | 10 | 0 |
| 2001 | 7 | 0 |
| 2002 | 12 | 0 |
| 2003 | 10 | 0 |
| 2004 | 2 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 11 | 0 |
| 2025 | 33 | 0 |
| 2026 | 16 | 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 |
|---|---|---|---|
| * | K121435 | Silkn BlueSummary page 4…Silver Bay, LLC NutraLuxe MD, LLC Device Name Acne Treatment device Quasar Calypso Nutra Light Red 510(k) Number K121435 K111286 K141308 Product Code OLP OLP… | 2013 |
| * | K111286 | Quasar CalypsoSummary page 4…aLuxe MD, LLC Device Name Acne Treatment device Quasar Calypso Nutra Light Red 510(k) Number K121435 K111286 K141308 Product Code OLP OLP OHS Regulation… | 2012 |
| * | K141308 | Nutra Light RedSummary page 4…Name Acne Treatment device Quasar Calypso Nutra Light Red 510(k) Number K121435 K111286 K141308 Product Code OLP OLP OHS Regulation… | 2014 |
What descends from it? (75)
See all 755 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 22 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 148 ancestors have a recall of any class.
- Of its descendants, K171821 (Heat IN A Click, 2018) has gone furthest, with 58 descendants of its own.
- 7 other devices also cite its predicate K121435.
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. 2017, 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?
The red light is intended for the treatment of periorbital wrinkles, and the blue light is intended for the treatment of the mild to moderate inflammatory acne.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162098 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162098: LED Phototherapy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162098
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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