510(k) · Cleared
ClearedSculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Kaiyan Medical Equipment Co., Ltd. · OLI Fat Reducing Low Level Laser
Cleared on May 4, 2026 as substantially equivalent to K241947 (Shenzhen Kaiyan Medical Equipment Co., Ltd., 2025) and 4 other predicates after a 62-day review. Its family tree reaches back 20 generations to 1995.
- Decided
- May 4, 2026
- Review
- 62 days
- Class
- Class II
- Product code
- OLI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 20 generations to K943450 (1995). 197 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations between
- 3 generations backK202955 Contour Light CL-100Contour Research, LLC · 2021
- 2 generations backK232977 Biophotas Celluma CONTOURBiophotas, Inc. · 2023
- 1 generation backK241947 EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
- This deviceK260688 Sculpt LED Belt…Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026
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 backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 15 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 14 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 13 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 12 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 11 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 9 generations backK050397 Velasmooth, ShaperSyneron Medical, Ltd. · 2005
- 8 generations backK053611 SmoothshapesBicellulase, Inc. · 2006
- 7 generations backK061603 SmoothshapesBiocellulase, Inc. · 2006
- 6 generations backK101366 I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd. · 2010
- 5 generations backK111501 I-Lipo SystemChromogenex Technologies Limited · 2012
- 4 generations backK130341 Strawberry, Strawberry & CreamLaser Lipo Limited · 2013
- 3 generations backK202955 Contour Light CL-100Contour Research, LLC · 2021
- 2 generations backK232977 Biophotas Celluma CONTOURBiophotas, Inc. · 2023
- 1 generation backK241947 EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
- This deviceK260688 Sculpt LED Belt…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 |
|---|---|---|---|---|---|
| −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 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −15 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −14 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −13 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −12 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −11 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −9 | K050397 | Velasmooth, Shaper | Syneron Medical, Ltd. | 2005 | — |
| −8 | K053611 | Smoothshapes | Bicellulase, Inc. | 2006 | — |
| −7 | K061603 | Smoothshapes | Biocellulase, Inc. | 2006 | — |
| −6 | K101366 | I-Lipo, Models A00-1238 (230V), A00-1239 (120V) | Chromogenex Technologies, Ltd. | 2010 | — |
| −5 | K111501 | I-Lipo System | Chromogenex Technologies Limited | 2012 | — |
| −4 | K130341 | Strawberry, Strawberry & Cream | Laser Lipo Limited | 2013 | — |
| −3 | K202955 | Contour Light CL-100 | Contour Research, LLC | 2021 | — |
| −2 | K232977 | Biophotas Celluma CONTOUR | Biophotas, Inc. | 2023 | — |
| −1 | K241947 | EnergyLounger (TY-01) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025 | — |
| 0 (this device) | K260688 | Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 10 | 0 |
| 1995 | 10 | 0 |
| 1996 | 14 | 0 |
| 1997 | 17 | 0 |
| 1998 | 10 | 0 |
| 1999 | 6 | 0 |
| 2000 | 12 | 0 |
| 2001 | 8 | 0 |
| 2002 | 15 | 0 |
| 2003 | 10 | 0 |
| 2004 | 5 | 0 |
| 2005 | 8 | 0 |
| 2006 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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 OLI? 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 OLI device
- #1 K232977 Biophotas Celluma CONTOURscore 23.5 · 18 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 |
|---|---|---|---|
| * | K241947 | EnergyLounger (TY-01)Summary page 5…lastic Surgery Product Code: OLI, ILY Regulation Number:21 CFR 878.5400,21 CFR 890.5500 Regulation Class: II 3. Predicate Device Information Energy Lounger(TY-01) under K241947 cleared by Shenzhen Kaiyan Medical Equipment Co.,Ltd Biophotas Celluma CONTOUR under K232977 cleared by Biophotas Inc Contour Lig… | 2025 |
| * | K232977 | Biophotas Celluma CONTOURSummary page 5…ation Class: II 3. Predicate Device Information Energy Lounger(TY-01) under K241947 cleared by Shenzhen Kaiyan Medical Equipment Co.,Ltd Biophotas Celluma CONTOUR under K232977 cleared by Biophotas Inc Contour Light (CL-100) under K243854 cleared by Contour Research, LLC Contour Light (CL-100) under K2029… | 2023 |
| * | K243854 | Contour Light (CL-100)Summary page 5…r(TY-01) under K241947 cleared by Shenzhen Kaiyan Medical Equipment Co.,Ltd Biophotas Celluma CONTOUR under K232977 cleared by Biophotas Inc Contour Light (CL-100) under K243854 cleared by Contour Research, LLC Contour Light (CL-100) under K202955 cleared by Contour Research, LLC Erchonia® Emerald Laser(Mo… | 2026 |
| * | K202955 | Contour Light CL-100Summary page 5….,Ltd Biophotas Celluma CONTOUR under K232977 cleared by Biophotas Inc Contour Light (CL-100) under K243854 cleared by Contour Research, LLC Contour Light (CL-100) under K202955 cleared by Contour Research, LLC Erchonia® Emerald Laser(Model# SHL) under K192544 cleared by Erchonia Corporation Reference: Cel… | 2021 |
| * | K192544 | Erchonia EmeraldSummary page 5…t (CL-100) under K243854 cleared by Contour Research, LLC Contour Light (CL-100) under K202955 cleared by Contour Research, LLC Erchonia® Emerald Laser(Model# SHL) under K192544 cleared by Erchonia Corporation Reference: Cellulize under K180338 cleared by Ward Photonics LLC 4. Device Description The Scul… | 2020 |
| † | K180338 | Cellulize | 2018 |
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 11 companies; a new generation was cleared every 1.2 years on median.
- 6 of the 197 ancestors have a recall of any class.
How does its category compare?
All OLI devicesOLI Fat Reducing Low Level Laser: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · OLI
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLI
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLI
No recall names OLI since 2007.
Adverse event reports per year · OLI
2in 2023
MAUDE reports naming product code OLI, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 4 | 93 | 0 | 0 |
| 2013 | 3 | 101 | 0 | 4 |
| 2014 | 3 | 159 | 0 | 0 |
| 2015 | 3 | 90 | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 3 | 121 | 0 | 2 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 3 | 90 | 0 | 0 |
| 2026 | 3 | 89 | 0 | — |
What is it indicated for?
For model HY-150A/HY-150B/HY-200A/HY-200B/HY-420A: M1 is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. M2 and M3 are intended to deliver heat in the Red+IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis, and muscle spasm; relieving stiffness; promoting the…
Read the full statement (161 words)
For model HY-150A/HY-150B/HY-200A/HY-200B/HY-420A:
M1 is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.
M2 and M3 are intended to deliver heat in the Red+IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis, and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
For model HY-200D/HY-200C
M3 is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of body circumference in individuals with a Body Mass Index (BMI) up to 40 kg/m2.
M1 and M2 are intended to deliver heat in the Red, IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis, and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260688: Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260688
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026