510(k) · Cleared
ClearedORA Method LED Gua Sha (GS-04)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Kaiyan Medical Equipment Co., Ltd. · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Oct 9, 2025 as substantially equivalent to K250761 (Shenzhen Kaiyan Medical Equipment Co., Ltd., 2025) and 2 other predicates after a 79-day review. Its family tree reaches back 22 generations to 1995.
- Decided
- Oct 9, 2025
- Review
- 79 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 22 generations to K943450 (1995). 317 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 22 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 18 generations between
- 3 generations backK241857 LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd · 2024
- 2 generations backK242700 Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70…Shenzhen Nuon Medical Equipment Co., Ltd. · 2024
- 1 generation backK250761 KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
- This deviceK252272 ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
Show all 22 generations
- Root · 22 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 21 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 20 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 19 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 18 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 17 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 16 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 15 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 14 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 13 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 12 generations backK123999 Illumask Acne Light Therapy MaskLa Lumiere, LLC · 2013
- 11 generations backK140471 Pro X Otc 5La Lumiere, LLC · 2015
- 10 generations backK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
- 9 generations backK170984 LG Beauty Led MaskLg Electronics · 2017
- 8 generations backK180856 Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc. · 2018
- 7 generations backK190443 MMSphereGalactic Beauty, LLC · 2019
- 6 generations backK202390 Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd. · 2021
- 5 generations backK220168 Skin Care Beauty Mask (Model: MJ-06)Shenzhen Kaiyan Medical CO, Ltd. · 2022
- 4 generations backK230351 LED Facial MaskShenzhen Sungpo Hi-Tech Electronic Co., Ltd. · 2023
- 3 generations backK241857 LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd · 2024
- 2 generations backK242700 Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70…Shenzhen Nuon Medical Equipment Co., Ltd. · 2024
- 1 generation backK250761 KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
- This deviceK252272 ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −21 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −20 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −19 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −18 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −17 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −16 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −15 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −14 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −13 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| −12 | K123999 | Illumask Acne Light Therapy Mask | La Lumiere, LLC | 2013 | — |
| −11 | K140471 | Pro X Otc 5 | La Lumiere, LLC | 2015 | — |
| −10 | K163329 | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 | Pulsaderm, LLC | 2017 | — |
| −9 | K170984 | LG Beauty Led Mask | Lg Electronics | 2017 | — |
| −8 | K180856 | Neutrogena Light Therapy Aging Mask+ | Johnson & Johnson Consumer, Inc. | 2018 | — |
| −7 | K190443 | MMSphere | Galactic Beauty, LLC | 2019 | — |
| −6 | K202390 | Aduro Light Beauty Mask | Shenzhen Kaiyan Medical CO, Ltd. | 2021 | — |
| −5 | K220168 | Skin Care Beauty Mask (Model: MJ-06) | Shenzhen Kaiyan Medical CO, Ltd. | 2022 | — |
| −4 | K230351 | LED Facial Mask | Shenzhen Sungpo Hi-Tech Electronic Co., Ltd. | 2023 | — |
| −3 | 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 | — |
| −1 | K250761 | KALA Therapy Wand (Model: KALA-03) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025 | — |
| 0 (this device) | K252272 | ORA Method LED Gua Sha (GS-04) | Shenzhen Kaiyan Medical Equipment 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 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 6 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 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? (3)
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 |
|---|---|---|---|
| * | K250761 | KALA Therapy Wand (Model: KALA-03)Summary page 5…Review Panel: General & Plastic Surgery Product Code: OHS, ISA Regulation Number:21 CFR 878.4810 Regulation Class: II 3.Predicate Device Information Predicate Device 1 (K250761) Sponsor: Shenzhen Kaiyan Medical Equipment Co.,Ltd Trade Name: KALA Therapy Wand (Model: KALA-03) Classification Name: Therapeut… | 2025 |
| * | K242382 | décoLITE LED DeviceSummary page 6…ISA Regulation Number: 21 CFR 890.5660,21 CFR 878.4810 Regulation Class: II 1/6 Predicate Device 2 (K242382) Sponsor: ISMART DEVELOPMENTS LTD Trade Name: décoLITE Classification Name: Light Based Over The Counter Wrinkle Reduction Review… | 2024 |
| * | K242700 | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Summary page 6…Over The Counter Wrinkle Reduction Review Panel: General & Plastic Surgery Product Code: OHS Regulation Number: 21 CFR 878.4810 Regulation Class: II Predicate Device 3 (K242700) Sponsor: Shenzhen Nuon Medical Equipment Co., Ltd Radiant Renewal Skincare Lid (Model: HD-59A, HD-59B, HD-72, HD-73A, HD-116, HD… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 15 companies; a new generation was cleared every 12 months on median.
- 12 of the 317 ancestors have a recall of any class.
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 ORA Method LED Gua Sha (Model: GS-04) is an Over-the-Counter (OTC) device indicated to emit energy in red and infrared region of the spectrum for treatment of full-face and decolletage wrinkles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252272 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252272: ORA Method LED Gua Sha (GS-04).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252272
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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