510(k) · Cleared
ClearedreVive Light Therapy Essentials
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Led Technologies, Inc. · OLP Over-The-Counter Powered Light Based Laser For Acne
Cleared on Dec 21, 2021 as substantially equivalent to K180447 (Led Technologies, Inc., 2018) and 1 other predicate after a 265-day review. Its family tree reaches back 15 generations to 1995. 3 later devices descend from it.
- Decided
- Dec 21, 2021
- Review
- 265 days
- Class
- Class II
- Product code
- OLP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K943450 (1995). 111 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations between
- 3 generations backK142246 LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC · 2015
- 2 generations backK160691 Acne Light Therapy WandZuko, Inc. · 2016
- 1 generation backK180320 dpl IIa PanelLed Technologies, Inc. · 2018
- This deviceK210968 reVive Light Therapy EssentialsLed Technologies, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK223482 reVive Light Therapy® Wrinkle and Acne LED DeviceLed Technologies, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK243587 PureLift GLOWXtreem Pulse, LLC · 2025
- Descendant · 3 generations on · 0 of its ownK261370 LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd. · 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 backK131461 Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC · 2014
- 3 generations backK142246 LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC · 2015
- 2 generations backK160691 Acne Light Therapy WandZuko, Inc. · 2016
- 1 generation backK180320 dpl IIa PanelLed Technologies, Inc. · 2018
- This deviceK210968 reVive Light Therapy EssentialsLed Technologies, Inc. · 2021
Most influential descendants
Showing 3 of 3 · See all- K223482reVive Light Therapy® Wrinkle and Acne LED DeviceLed Technologies, Inc. · 2022 · cites it directly2descendants
- K243587PureLift GLOWXtreem Pulse, LLC · 2025 · 2 generations on1descendant
- K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd. · 2026 · 3 generations on0descendants
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 | K131461 | Lightstim for Acne/ Lightstim for Acne Mini | Led Intellectual Properties, LLC | 2014 | — |
| −3 | K142246 | LightStim for Acne/ LightStim for Acne Mini | Led Intellectual Properties, LLC | 2015 | — |
| −2 | K160691 | Acne Light Therapy Wand | Zuko, Inc. | 2016 | — |
| −1 | K180320 | dpl IIa Panel | Led Technologies, Inc. | 2018 | — |
| 0 (this device) | K210968 | reVive Light Therapy Essentials | Led Technologies, Inc. | 2021 | — |
| +1 | K223482 | reVive Light Therapy® Wrinkle and Acne LED Device | Led Technologies, Inc. | 2022 | — |
| +2 | K243587 | PureLift GLOW | Xtreem Pulse, LLC | 2025 | — |
| +3 | K261370 | LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) | Guangdong Newdermo Biotech Co., Ltd. | 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 | 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 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
| 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 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 25.6 · 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? (2)
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 |
|---|---|---|---|
| * | K180447 | reVive Light Therapy LED Cleansing SystemSummary page 5…apy® Essentials is an Over the Counter (OTC) LED device intended for use in treating mild to moderate inflammatory acne. 4. Predicate Devices: Primary Predicate - K180447 – reVive Light Therapy® LED Cleansing System (LED Technologies, Inc.) K180320 – dpl® IIa Panel (LED Technologies, Inc.)… | 2018 |
| * | K180320 | dpl IIa PanelSummary page 5…ng mild to moderate inflammatory acne. 4. Predicate Devices: Primary Predicate - K180447 – reVive Light Therapy® LED Cleansing System (LED Technologies, Inc.) K180320 – dpl® IIa Panel (LED Technologies, Inc.) Comparison Chart Device reVive Light dpl® IIa Panel… | 2018 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223482 | reVive Light Therapy® Wrinkle and Acne LED Device | 2022 | 2 |
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 26 years and passes through 9 companies; a new generation was cleared every 1.1 years on median.
- 4 of the 111 ancestors have a recall of any class.
- Of its descendants, K223482 (Led Technologies, Inc., 2022) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K180447.
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. 2021, 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 reVive Light Therapy® Essentials is an Over the Counter (OTC) device intended for 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/K210968 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210968: reVive Light Therapy Essentials.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210968
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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