510(k) · Cleared
ClearedElevare, Perfectio 4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omm Imports D/B/A Zero Gravity · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Jun 7, 2018 as substantially equivalent to K141181 (Led Technologies, LLC, 2015) after a 255-day review. Its family tree reaches back 4 generations to 2010. 11 later devices descend from it.
- Decided
- Jun 7, 2018
- Review
- 255 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K101190 (2010). 5 ancestors in all. 11 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK101190 Lightstim Anti-Wrinkle Otc Model Aal OtcLed Intellectual Properties, LLC · 2010
- 3 generations backK120775 Light for WrinklesLed Intellectual Properties, LLC · 2012
- 2 generations backK120560 Trinity Wrinkle RemoverCarol Cole Company · 2012
- 1 generation backK141181 Nuve for Wrinkles, DPL Nuve for WrinklesLed Technologies, LLC · 2015
- This deviceK172909 Elevare, Perfectio 4Omm Imports D/B/A Zero Gravity · 2018
- Descendant · cites it directly · 3 of its ownK210954 SynergyYrs Group, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK202055 Looper (Model: ZX-579S)Heat IN A Click, LLC · 2021
- Descendant · 2 generations on · 2 of its ownK240360 Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd. · 2024
- Descendant · cites it directly · 2 of its ownK210545 Infrared Red blue LED light heat beauty machine, Infrared Red blue…Marci Beauty, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK261370 LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd. · 2026
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K210954SynergyYrs Group, Inc. · 2021 · cites it directly3descendants
- K202055Looper (Model: ZX-579S)Heat IN A Click, LLC · 2021 · cites it directly3descendants
- K240360Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd. · 2024 · 2 generations on2descendants
- K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc. · 2022 · cites it directly2descendants
- 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 |
|---|---|---|---|---|---|
| −4 | K101190 | Lightstim Anti-Wrinkle Otc Model Aal Otc | Led Intellectual Properties, LLC | 2010 | — |
| −3 | K120775 | Light for Wrinkles | Led Intellectual Properties, LLC | 2012 | — |
| −2 | K120560 | Trinity Wrinkle Remover | Carol Cole Company | 2012 | — |
| −1 | K141181 | Nuve for Wrinkles, DPL Nuve for Wrinkles | Led Technologies, LLC | 2015 | — |
| 0 (this device) | K172909 | Elevare, Perfectio 4 | Omm Imports D/B/A Zero Gravity | 2018 | — |
| +1 | K210954 | Synergy | Yrs Group, Inc. | 2021 | — |
| +1 | K202055 | Looper (Model: ZX-579S) | Heat IN A Click, LLC | 2021 | — |
| +2 | K240360 | Wrinkle Treatment Device (JM2) | Shenzhen Qianyu Technology Co., Ltd. | 2024 | — |
| +1 | K210545 | Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light… | Marci Beauty, Inc. | 2022 | — |
| +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 |
|---|---|---|
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K141181 | Nuve for Wrinkles, DPL Nuve for WrinklesSummary page 4…Division of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) 3. Predicate Device(s): Predicate Device: K141181 -NUVE for Wrinkles (LED Technologies, LLC) Reference Devices: 1. K120775 – LightStim for Wrinkles (LED Intellectual) 2. K… | 2015 |
| † | K120775 | Light for Wrinkles | 2012 |
| † | K120560 | Trinity Wrinkle Remover | 2012 |
What descends from it? (11)
See all 113 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 2.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K210954 (Yrs Group, Inc., 2021) has gone furthest, with 3 descendants 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 Elevare Plus is an Over-the-Counter (OTC) device intended for the use in treating wrinkles on the face.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172909 · printed Nov 5, 2026
Cite this page
510(k) Report. “K172909: Elevare, Perfectio 4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K172909
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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