510(k) · Cleared
ClearedSynergy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yrs Group, Inc. · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Jun 29, 2021 as substantially equivalent to K172909 (Omm Imports D/B/A Zero Gravity, 2018) after a 91-day review. Its family tree reaches back 5 generations to 2010. 3 later devices descend from it.
- Decided
- Jun 29, 2021
- Review
- 91 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K101190 (2010). 6 ancestors in all. 3 later devices descend from it, 1 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 backK172909 Elevare, Perfectio 4Omm Imports D/B/A Zero Gravity · 2018
- This deviceK210954 SynergyYrs Group, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK240360 Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK261370 LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK244020 Wrinkle Treatment Device (JM1, JM2B)Shenzhen Qianyu Technology Co., Ltd. · 2025
Most influential descendants
Showing 3 of 3 · See all- K240360Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd. · 2024 · cites it directly2descendants
- K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd. · 2026 · 2 generations on0descendants
- K244020Wrinkle Treatment Device (JM1, JM2B)Shenzhen Qianyu Technology Co., Ltd. · 2025 · 2 generations on0descendants
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 | K172909 | Elevare, Perfectio 4 | Omm Imports D/B/A Zero Gravity | 2018 | — |
| 0 (this device) | K210954 | Synergy | Yrs Group, Inc. | 2021 | — |
| +1 | K240360 | Wrinkle Treatment Device (JM2) | Shenzhen Qianyu Technology Co., Ltd. | 2024 | — |
| +2 | K261370 | LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) | Guangdong Newdermo Biotech Co., Ltd. | 2026 | — |
| +2 | K244020 | Wrinkle Treatment Device (JM1, JM2B) | Shenzhen Qianyu Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 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 |
|---|---|---|---|
| * | K172909 | Elevare, Perfectio 4Summary page 4…arameters New Device Predicate Device Remark 510(k) number K210954 K172909 -- Device name SYNERGY Elevare Plus… | 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 |
|---|---|---|---|
| K240360 | Wrinkle Treatment Device (JM2) | 2024 | 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 11 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K240360 (Shenzhen Qianyu Technology Co., Ltd., 2024) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K172909.
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 SYNERGY is an Over-the-Counter (OTC) device intended for the use in treating wrinkles on the face.
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/K210954 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210954: Synergy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210954
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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