510(k) · Cleared
Clearedeasy Claire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Y & J Bio Co., Ltd. · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Mar 3, 2022 as substantially equivalent to K133896 (Trophy Skin, Inc., 2014) after a 153-day review. Its family tree reaches back 3 generations to 2010. 3 later devices descend from it.
- Decided
- Mar 3, 2022
- Review
- 153 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K101190 (2010). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK101190 Lightstim Anti-Wrinkle Otc Model Aal OtcLed Intellectual Properties, LLC · 2010
- 2 generations backK120775 Light for WrinklesLed Intellectual Properties, LLC · 2012
- 1 generation backK133896 Rejuvalite MDTrophy Skin, Inc. · 2014
- This deviceK213285 easy ClaireY & J Bio Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK243393 JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG…Shenzhen Ulike Smart Electronics Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK260895 Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK223278 easy ClaireY & J Bio Co., Ltd. · 2022
Most influential descendants
Showing 3 of 3 · See all- K243393JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)Shenzhen Ulike Smart Electronics Co., Ltd. · 2025 · cites it directly1descendant
- K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd. · 2026 · 2 generations on0descendants
- K223278easy ClaireY & J Bio Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K101190 | Lightstim Anti-Wrinkle Otc Model Aal Otc | Led Intellectual Properties, LLC | 2010 | — |
| −2 | K120775 | Light for Wrinkles | Led Intellectual Properties, LLC | 2012 | — |
| −1 | K133896 | Rejuvalite MD | Trophy Skin, Inc. | 2014 | — |
| 0 (this device) | K213285 | easy Claire | Y & J Bio Co., Ltd. | 2022 | — |
| +1 | K243393 | JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK… | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025 | — |
| +2 | K260895 | Ulike Clear Zero (YC10 BU) | Guangxi Ulike Medical Technology Co., Ltd. | 2026 | — |
| +1 | K223278 | easy Claire | Y & J Bio Co., Ltd. | 2022 | — |
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 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.
What descends from it? (3)
2 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 12 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K243393 (Shenzhen Ulike Smart Electronics Co., Ltd., 2025) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K133896.
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. 2022, 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 easy Claire is an over-the-counter medical device intended for the use in the treatment of full face wrinkles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213285: easy Claire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213285
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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