510(k) · Cleared
ClearedBeauty LED Mask, Model: KFB265
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hunan Guangye Biotechnology Co., Ltd. · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Jul 19, 2022 as substantially equivalent to K183671 (Lg Electronics.Inc, 2019) after a 90-day review. Its family tree reaches back 15 generations to 1995. 41 later devices descend from it.
- Decided
- Jul 19, 2022
- Review
- 90 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K943450 (1995). 96 ancestors in all, the oldest K800617 (1980). 41 later devices descend from it, 4 citing it directly.
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations between
- 3 generations backK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
- 2 generations backK170984 LG Beauty Led MaskLg Electronics · 2017
- 1 generation backK183671 LG Pra.L Derma Led MaskLg Electronics.Inc · 2019
- This deviceK221151 Beauty LED Mask, Model: KFB265Hunan Guangye Biotechnology Co., Ltd. · 2022
- Descendant · cites it directly · 39 of its ownK223544 LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd. · 2023
- Descendant · cites it directly · 21 of its ownK241857 LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd · 2024
- Descendant · 2 generations on · 6 of its ownK242700 Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70…Shenzhen Nuon Medical Equipment Co., Ltd. · 2024
- Descendant · 2 generations on · 3 of its ownK242385 LED Therapy Mask (MN1, M226)Shenzhen Borria Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 3 of its ownK243423 LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G…Shenzhen Rainbow Technology Co., Ltd. · 2025
Show all 15 generations
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 10 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 9 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 8 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 7 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 6 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 5 generations backK123999 Illumask Acne Light Therapy MaskLa Lumiere, LLC · 2013
- 4 generations backK140471 Pro X Otc 5La Lumiere, LLC · 2015
- 3 generations backK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
- 2 generations backK170984 LG Beauty Led MaskLg Electronics · 2017
- 1 generation backK183671 LG Pra.L Derma Led MaskLg Electronics.Inc · 2019
- This deviceK221151 Beauty LED Mask, Model: KFB265Hunan Guangye Biotechnology Co., Ltd. · 2022
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd. · 2023 · cites it directly39descendants
- K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd · 2024 · cites it directly21descendants
- K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd. · 2024 · 2 generations on6descendants
- K242385LED Therapy Mask (MN1, M226)Shenzhen Borria Technology Co., Ltd. · 2025 · 2 generations on3descendants
- K243423LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J…Shenzhen Rainbow Technology Co., Ltd. · 2025 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −14 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −10 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −9 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −8 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −7 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −6 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| −5 | K123999 | Illumask Acne Light Therapy Mask | La Lumiere, LLC | 2013 | — |
| −4 | K140471 | Pro X Otc 5 | La Lumiere, LLC | 2015 | — |
| −3 | K163329 | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 | Pulsaderm, LLC | 2017 | — |
| −2 | K170984 | LG Beauty Led Mask | Lg Electronics | 2017 | — |
| −1 | K183671 | LG Pra.L Derma Led Mask | Lg Electronics.Inc | 2019 | — |
| 0 (this device) | K221151 | Beauty LED Mask, Model: KFB265 | Hunan Guangye Biotechnology Co., Ltd. | 2022 | — |
| +1 | K223544 | LED light therapy mask (FM-01, FM-02, FM-03) | Guangdong Newdermo Biotech Co., Ltd. | 2023 | — |
| +1 | K241857 | LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) | Dongguan Boyuan Intelligent Technology Co.,Ltd | 2024 | — |
| +2 | K242700 | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72… | Shenzhen Nuon Medical Equipment Co., Ltd. | 2024 | — |
| +2 | K242385 | LED Therapy Mask (MN1, M226) | Shenzhen Borria Technology Co., Ltd. | 2025 | — |
| +2 | K243423 | LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB… | Shenzhen Rainbow Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 8 | 0 |
| 1995 | 9 | 0 |
| 1996 | 12 | 0 |
| 1997 | 13 | 0 |
| 1998 | 8 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 25 | 0 |
| 2026 | 11 | 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? (41)
See all 414 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 27 years and passes through 10 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 96 ancestors have a recall of any class.
- Of its descendants, K223544 (Guangdong Newdermo Biotech Co., Ltd., 2023) has gone furthest, with 39 descendants of its own.
- 2 other devices also cite its predicate K183671.
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 device is intended to use LED light for the treatment of wrinkles and mild to moderate acne.
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/K221151 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221151: Beauty LED Mask, Model: KFB265.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221151
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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