510(k) · Cleared
ClearedLED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Fittop Health Technology Co., Ltd. · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Aug 21, 2025 as substantially equivalent to K242593 (Shenzhen Kaiyan Medical Equipment Co., Ltd., 2025) and 4 other predicates after a 90-day review. Its family tree reaches back 20 generations to 1995. 2 later devices descend from it.
- Decided
- Aug 21, 2025
- Review
- 90 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 20 generations to K943450 (1995). 318 ancestors in all, the oldest K800617 (1980). 2 later devices descend from it, 2 citing it directly.
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations between
- 3 generations backK220168 Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd. · 2022
- 2 generations backK230351 LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd. · 2023
- 1 generation backK241857 LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd · 2024
- This deviceK251588 LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908…Shenzhen Fittop Health Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK260715 CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK253054 LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. · 2025
Show all 20 generations
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 19 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 16 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 15 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 14 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 13 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 12 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 11 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 10 generations backK123999 Illumask Acne Light Therapy MaskLa Lumiere, LLC · 2013
- 9 generations backK140471 Pro X Otc 5La Lumiere, LLC · 2015
- 8 generations backK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
- 7 generations backK170984 LG Beauty Led MaskLg Electronics · 2017
- 6 generations backK180856 Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc. · 2018
- 5 generations backK190443 MMSphereGalactic Beauty, LLC · 2019
- 4 generations backK202390 Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd. · 2021
- 3 generations backK220168 Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd. · 2022
- 2 generations backK230351 LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd. · 2023
- 1 generation backK241857 LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd · 2024
- This deviceK251588 LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908…Shenzhen Fittop Health Technology Co., Ltd. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −19 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −16 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −15 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −14 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −13 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −12 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −11 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| −10 | K123999 | Illumask Acne Light Therapy Mask | La Lumiere, LLC | 2013 | — |
| −9 | K140471 | Pro X Otc 5 | La Lumiere, LLC | 2015 | — |
| −8 | K163329 | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 | Pulsaderm, LLC | 2017 | — |
| −7 | K170984 | LG Beauty Led Mask | Lg Electronics | 2017 | — |
| −6 | K180856 | Neutrogena Light Therapy Aging Mask+ | Johnson & Johnson Consumer, Inc. | 2018 | — |
| −5 | K190443 | MMSphere | Galactic Beauty, LLC | 2019 | — |
| −4 | K202390 | Aduro Light Beauty Mask | Shenzhen Kaiyan Medical CO, Ltd. | 2021 | — |
| −3 | K220168 | Skin Care Beauty Mask (Model: MJ-06) | Shenzhen Kaiyan Medical CO, Ltd. | 2022 | — |
| −2 | K230351 | LED Facial Mask | Shenzhen Sungpo Hi-Tech Electronic Co., Ltd. | 2023 | — |
| −1 | K241857 | LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) | Dongguan Boyuan Intelligent Technology Co.,Ltd | 2024 | — |
| 0 (this device) | K251588 | LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) | Shenzhen Fittop Health Technology Co., Ltd. | 2025 | — |
| +1 | K260715 | CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) | The Beauty Tech Group, Ltd. | 2026 | — |
| +1 | K253054 | LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) | Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 11 | 0 |
| 1995 | 13 | 0 |
| 1996 | 17 | 0 |
| 1997 | 20 | 0 |
| 1998 | 15 | 0 |
| 1999 | 7 | 0 |
| 2000 | 22 | 0 |
| 2001 | 24 | 0 |
| 2002 | 29 | 0 |
| 2003 | 20 | 0 |
| 2004 | 13 | 0 |
| 2005 | 13 | 0 |
| 2006 | 3 | 0 |
| 2007 | 5 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 6 | 0 |
| 2018 | 6 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 5 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K242593 | CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Summary page 5…rentBody™ LED 4 in 1 Zone Facial Mapping Mask Device Name and Model (MK-90C, MK-90M, MK66RB-F, MK-90N) 510(k) Number K242593 Product Code OHS, OLP Regulation Number 21 CFR 878.4810… | 2025 |
| * | K241857 | LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Summary page 6…LED Light Therapy Device (KFB290, KFB291, KFB265, Device Name and Model KFB293) 510(k) Number K241857 Product Code OHS, OLP, ILY Regulation Number 21 CFR 878.4810, 21 CFR 890.5500 Regulation Class… | 2024 |
| * | K242796 | CryoGlow (FW3XXXX)Summary page 6…II Predicate device 3 Sponsor SharkNinja Operating, LLC Device Name and Model CryoGlow (FW3XXXX) 510(k) Number K242796 Product Code OHS, OLP Regulation Number 21 CFR 878.4810 Regulation Class II … | 2024 |
| * | K230351 | LED Facial MaskSummary page 6…Shenzhen SUNGPO HI-TECH Electronic Co.,Ltd Device Name and Model LED Facial Mask/MZ-01, NEWKEY-01, SP-FM-01 510(k) Number K230351 Product Code OHS, OLP Regulation Number 21 CFR 878.4810 Regulation Class II … | 2023 |
| * | K230042 | Q-Rejuvalight Pro Facewear (Model: P19-0023)Summary page 6…Shenzhen Kaiyan Medical Equipment Co., Ltd Device Name and Model Q-Rejuvalight Pro Facewear (Model: P19-0023) 510(k) Number K230042 Product Code OHS, OLP Regulation Number 21 CFR 878.4810 Regulation Class II (5)… | 2023 |
What descends from it? (2)
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 30 years and passes through 14 companies; a new generation was cleared every 1.0 years on median.
- 12 of the 318 ancestors have a recall of any class.
- Of its descendants, K260715 (The Beauty Tech Group, Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K242593.
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. 2025, 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 LED Light Therapy Mask (Model: FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne. FCM902, FCM905, FCM906, FCM908: a.Red light: Treatment of full-face wrinkles. b.Blue+Infrared light: Treatment of mild to moderate inflammatory acne. c.Yellow+Infrared light: Treatment of full-face wrinkles. 11-001-RBMASK: a.Red+Infrared light: Treatment of…
Read the full statement (91 words)
The LED Light Therapy Mask (Model: FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne.
FCM902, FCM905, FCM906, FCM908:
a.Red light: Treatment of full-face wrinkles.
b.Blue+Infrared light: Treatment of mild to moderate inflammatory acne.
c.Yellow+Infrared light: Treatment of full-face wrinkles.
11-001-RBMASK:
a.Red+Infrared light: Treatment of full-face wrinkles.
b.Blue light: Treatment of mild to moderate inflammatory acne.
FCM910:
a.Red+Infrared light: Treatment of full-face wrinkles.
b.Blue light: Treatment of mild to moderate inflammatory acne.
c.Yellow+Infrared light: Treatment of full-face wrinkles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251588: LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251588
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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