510(k) · Cleared
ClearedreVive Perioral
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Led Technologies, Inc. · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Jan 9, 2018 as substantially equivalent to K141181 (Led Technologies, LLC, 2015) and 2 other predicates after a 126-day review. Its family tree reaches back 5 generations to 2010. 4 later devices descend from it.
- Decided
- Jan 9, 2018
- Review
- 126 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K101190 (2010). 7 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK101190 Lightstim Anti-Wrinkle Otc Model Aal OtcLed Intellectual Properties, LLC · 2010
- 4 generations backK120775 Light for WrinklesLed Intellectual Properties, LLC · 2012
- 3 generations backK120560 Trinity Wrinkle RemoverCarol Cole Company · 2012
- 2 generations backK141181 Nuve for Wrinkles, DPL Nuve for WrinklesLed Technologies, LLC · 2015
- 1 generation backK171390 dpl II PanelLed Technologies, Inc. · 2017
- This deviceK172662 reVive PerioralLed Technologies, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK213024 Oren LED Perioral Light Therapy SystemShenzhen Kaiyan Medical CO, Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK260202 LED Light Therapy Masks (LumiLips FAC07NA)Guangdong Newdermo Biotech Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK223642 LED Lip Perfector, model: ZC-05Light Tree Ventures Europe B.V. · 2023
- Descendant · cites it directly · 0 of its ownK212947 Trinity Plus Wrinkle ReducerCarol Cole Company Dba Nuface · 2022
Most influential descendants
Showing 4 of 4 · See all- K213024Oren LED Perioral Light Therapy SystemShenzhen Kaiyan Medical CO, Ltd. · 2021 · cites it directly1descendant
- K260202LED Light Therapy Masks (LumiLips FAC07NA)Guangdong Newdermo Biotech Co., Ltd. · 2026 · cites it directly0descendants
- K223642LED Lip Perfector, model: ZC-05Light Tree Ventures Europe B.V. · 2023 · cites it directly0descendants
- K212947Trinity Plus Wrinkle ReducerCarol Cole Company Dba Nuface · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K101190 | Lightstim Anti-Wrinkle Otc Model Aal Otc | Led Intellectual Properties, LLC | 2010 | — |
| −4 | K120775 | Light for Wrinkles | Led Intellectual Properties, LLC | 2012 | — |
| −3 | K120560 | Trinity Wrinkle Remover | Carol Cole Company | 2012 | — |
| −2 | K141181 | Nuve for Wrinkles, DPL Nuve for Wrinkles | Led Technologies, LLC | 2015 | — |
| −1 | K171390 | dpl II Panel | Led Technologies, Inc. | 2017 | — |
| 0 (this device) | K172662 | reVive Perioral | Led Technologies, Inc. | 2018 | — |
| +1 | K213024 | Oren LED Perioral Light Therapy System | Shenzhen Kaiyan Medical CO, Ltd. | 2021 | — |
| +1 | K260202 | LED Light Therapy Masks (LumiLips FAC07NA) | Guangdong Newdermo Biotech Co., Ltd. | 2026 | — |
| +1 | K223642 | LED Lip Perfector, model: ZC-05 | Light Tree Ventures Europe B.V. | 2023 | — |
| +1 | K212947 | Trinity Plus Wrinkle Reducer | Carol Cole Company Dba Nuface | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 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 |
|---|---|---|---|
| * | K141181 | Nuve for Wrinkles, DPL Nuve for WrinklesSummary page 5…vices: This device is substantially equivalent to the following predicate, which is currently legally marketed under product code OHS: • K141181 – dpl® Nuve for wrinkles (LED Technologies, Inc.) • K171390 – dpl® II Panel (LED Technologies, Inc.) •… | 2015 |
| * | K171390 | dpl II PanelSummary page 5…redicate, which is currently legally marketed under product code OHS: • K141181 – dpl® Nuve for wrinkles (LED Technologies, Inc.) • K171390 – dpl® II Panel (LED Technologies, Inc.) • K171386 – dpl® SpectraLite (LED Tchnologies, Inc.) Predicate C… | 2017 |
| * | K171386 | dpl SpectraLiteSummary page 5…uct code OHS: • K141181 – dpl® Nuve for wrinkles (LED Technologies, Inc.) • K171390 – dpl® II Panel (LED Technologies, Inc.) • K171386 – dpl® SpectraLite (LED Tchnologies, Inc.) Predicate Chart Device reVive® Perioral dpl® Nüve for… | 2017 |
What descends from it? (4)
4 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 8 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K213024 (Shenzhen Kaiyan Medical CO, Ltd., 2021) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K141181.
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. 2018, 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 reVive® Perioral LED Light Therapy system is an Over-the-Counter (OTC) device intended for treatment of fine lines and wrinkles, and increase in circulation within the perioral region.
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/K172662 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172662: reVive Perioral.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172662
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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