510(k) · Cleared
ClearedHIGHERDOSE Body Sculptor (Model: GS-03)
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 Jan 28, 2026 as substantially equivalent to K223893 (Light Tree Ventures Europe B.V., 2023) and 2 other predicates after a 163-day review. Its family tree reaches back 16 generations to 1995.
- Decided
- Jan 28, 2026
- Review
- 163 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K943450 (1995). 155 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations between
- 3 generations backK152280 BioPhotas Celluma3Biophotas, Inc. · 2016
- 2 generations backK200983 Infrared light therapy led facial light therapy mask-Derma plus…Ningbo Hesi Electric Co., Ltd. · 2021
- 1 generation backK242789 Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd. · 2025
- This deviceK252603 HIGHERDOSE Body Sculptor (Model: GS-03)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026
Show all 16 generations
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 12 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 10 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 9 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 8 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 7 generations backK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
- 6 generations backK060792 IllumimedPhotoactif, LLC · 2006
- 5 generations backK122237 Biophotas LifelightBiophotas, Inc. · 2013
- 4 generations backK131113 Biophotas CellumaBiophotas, Inc. · 2014
- 3 generations backK152280 BioPhotas Celluma3Biophotas, Inc. · 2016
- 2 generations backK200983 Infrared light therapy led facial light therapy mask-Derma plus…Ningbo Hesi Electric Co., Ltd. · 2021
- 1 generation backK242789 Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd. · 2025
- This deviceK252603 HIGHERDOSE Body Sculptor (Model: GS-03)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −15 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −12 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −10 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −9 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −8 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −7 | K042630 | Revlight Skin Care System | Skincare Technology, Inc. | 2005 | — |
| −6 | K060792 | Illumimed | Photoactif, LLC | 2006 | — |
| −5 | K122237 | Biophotas Lifelight | Biophotas, Inc. | 2013 | — |
| −4 | K131113 | Biophotas Celluma | Biophotas, Inc. | 2014 | — |
| −3 | K152280 | BioPhotas Celluma3 | Biophotas, Inc. | 2016 | — |
| −2 | K200983 | Infrared light therapy led facial light therapy mask-Derma plus, Photons… | Ningbo Hesi Electric Co., Ltd. | 2021 | — |
| −1 | K242789 | Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006) | Dongguan Laiguang Electronic Technology Co., Ltd. | 2025 | — |
| 0 (this device) | K252603 | HIGHERDOSE Body Sculptor (Model: GS-03) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 10 | 0 |
| 1996 | 12 | 0 |
| 1997 | 15 | 0 |
| 1998 | 11 | 0 |
| 1999 | 5 | 0 |
| 2000 | 10 | 0 |
| 2001 | 7 | 0 |
| 2002 | 12 | 0 |
| 2003 | 8 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K223893 | Infrared Heat (Model: E0221)Summary page 6…ion Sponsor: Light Tree Ventures Europe B.V. Trade Name: Infrared Heat, (Model: E0221) Classification Name: Light Based Over The Counter Wrinkle Reduction 510(K) Number: K223893 Review Panel: General & Plastic Surgery Product Code: OHS Regulation Number: 878.4810 Regulation Class: II Predicate Device 2 I… | 2023 |
| * | K250532 | Solawave 2-in-1 Skincare Mini (Model: 61043)Summary page 6…en Kaiyan Medical Equipment Co., Ltd Trade Name: Solawave 2-in-1 Skincare Mini (61043) Classification Name: Light Based Over The Counter Wrinkle Reduction 510(K) Number: K250532 Review Panel: General & Plastic Surgery Product Code: OHS Regulation Number: 878.4810 Regulation Class: II Predicate Device 3 I… | 2025 |
| * | K242789 | Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Summary page 6…Name: Bestqool LED therapy device Classification Name: Light Based Over The Counter Wrinkle Reduction, Over-The-Counter Powered Light Based Laser For Acne 510(K) Number: K242789 Review Panel: General & Plastic Surgery Product Code: OHS, OLP Regulation Number: 878.4810 Regulation Class: II 5. Device Descr… | 2025 |
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 31 years and passes through 10 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 155 ancestors have a recall of any class.
- 2 other devices also cite its predicate K223893.
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. 2026, 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 HIGHERDOSE BODY SCULPTOR (Model: GS-03) is an over-the-counter device that is intended to improve the appearance of wrinkles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252603 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252603: HIGHERDOSE Body Sculptor (Model: GS-03).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252603
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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