510(k) · Cleared
ClearedOren LED Perioral Light Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Kaiyan Medical CO, Ltd. · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Dec 22, 2021 as substantially equivalent to K172662 (Led Technologies, Inc., 2018) after a 92-day review. Its family tree reaches back 6 generations to 2010. 1 later device descends from it.
- Decided
- Dec 22, 2021
- Review
- 92 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K101190 (2010). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK101190 Lightstim Anti-Wrinkle Otc Model Aal OtcLed Intellectual Properties, LLC · 2010
- 5 generations backK120775 Light for WrinklesLed Intellectual Properties, LLC · 2012
- 4 generations backK120560 Trinity Wrinkle RemoverCarol Cole Company · 2012
- 3 generations backK141181 Nuve for Wrinkles, DPL Nuve for WrinklesLed Technologies, LLC · 2015
- 2 generations backK171390 dpl II PanelLed Technologies, Inc. · 2017
- 1 generation backK172662 reVive PerioralLed Technologies, Inc. · 2018
- This deviceK213024 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
Most influential descendants
Showing 1 of 1 · See all- K260202LED Light Therapy Masks (LumiLips FAC07NA)Guangdong Newdermo Biotech Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K101190 | Lightstim Anti-Wrinkle Otc Model Aal Otc | Led Intellectual Properties, LLC | 2010 | — |
| −5 | K120775 | Light for Wrinkles | Led Intellectual Properties, LLC | 2012 | — |
| −4 | K120560 | Trinity Wrinkle Remover | Carol Cole Company | 2012 | — |
| −3 | K141181 | Nuve for Wrinkles, DPL Nuve for Wrinkles | Led Technologies, LLC | 2015 | — |
| −2 | K171390 | dpl II Panel | Led Technologies, Inc. | 2017 | — |
| −1 | K172662 | reVive Perioral | Led Technologies, Inc. | 2018 | — |
| 0 (this device) | 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 | — |
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 |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K172662 | reVive PerioralSummary page 5…em Classification Name: Light Based Over-The-Counter Wrinkle Reduction device 1 / 4 510(K) Number: K172662 Review Panel: General & Plastic Surgery Product Code: OHS, ILY Regulation Number: 878.4810 Regulation Class: II 5. Device Descr… | 2018 |
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 |
|---|---|---|---|
| K260202 | LED Light Therapy Masks (LumiLips FAC07NA) | 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 11 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K260202 (Guangdong Newdermo Biotech Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K172662.
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. 2021, 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 Oren LED Perioral Light Therapy System (Model: OR-01) is an Over-the-Counter (OTC) device intended for the treatment fine lines and wrinkles, and increase in circulation within the perioral region.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213024 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213024: Oren LED Perioral Light Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213024
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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