Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)
FDA 510(k) K260688 · Shenzhen Kaiyan Medical Equipment Co., Ltd.
510(k) numberK260688
Submission
- Device name
- Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)
- Applicant
- Shenzhen Kaiyan Medical Equipment Co., Ltd.
Shenzhen, CN - Received
- March 3, 2026
- Decision date
- May 4, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLI – Fat Reducing Low Level Laser
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5400
- Specialty
- General, Plastic Surgery
Non-invasive reduction in fat layer for body contouring
Other 510(k)s with product code OLI
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|---|---|---|---|
| K260129 | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )OLI · Traditional | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 04/15/2026SE |
| K243854 | Contour Light (CL-100)OLI · Special | Contour Research, LLC | 02/13/2026SE |
| K252574 | Erchonia CLX (Model # CFL)OLI · Traditional | Erchonia Corporation | 12/15/2025SE |
| K252786 | Led Light Phototherapy Bed (Pro 450/ GY-680A)OLI · Traditional | Shenzhen Suyzeko Limited. | 12/01/2025SE |
| K243811 | Erchonia Zerona® VZ8OLI · Traditional | Erchonia Corporation | 01/10/2025SE |
| K232977 | Biophotas Celluma CONTOUROLI · Traditional | Biophotas, Inc. | 11/21/2023SE |
| K231474 | Erchonia Violet ZERONA® Z6 OTCOLI · Traditional | Erchonia Corporation | 07/21/2023SE |
| K220519 | Erchonia Zerona Z-BedOLI · Traditional | Erchonia Corporation | 03/24/2022SE |
| K213534 | PHantom TrilogyOLI · Traditional | Resurgeonz, LLC | 03/11/2022SE |
| K202955 | Contour Light CL-100OLI · Traditional | Contour Research, LLC | 05/19/2021SE |
More from Contour Research, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K253932 | FACEGYM Pro Device (HD-109)NFO · Traditional | 07/23/2026SE |
| K254025 | LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)OHS · Traditional | 06/16/2026SE |
| K260129 | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )OLI · Traditional | 04/15/2026SE |
| K253878 | LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)OLP · Traditional | 03/04/2026SE |
| K252603 | HIGHERDOSE Body Sculptor (Model: GS-03)OHS · Traditional | 01/28/2026SE |
| K253669 | Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth (M-130,M-300)OAP · Traditional | 01/23/2026SE |
| K252414 | Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)OAP · Traditional | 10/30/2025SE |
| K252272 | ORA Method LED Gua Sha (GS-04)OHS · Traditional | 10/09/2025SE |
| K251781 | Kala Mini 2.0 (KALA-04)OHS · Traditional | 09/04/2025SE |
| K251012 | TRUDERMAL Pro (ZLD-390)OHS · Traditional | 08/14/2025SE |
Questions and answers
When was Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) cleared by the FDA?
Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) (K260688) received a 510(k) decision of Substantially Equivalent on May 4, 2026, 62 days after the submission was received.
What is the product code of K260688?
The FDA product code is OLI – Fat Reducing Low Level Laser, a Class II (moderate risk) device regulated under 21 CFR 878.5400.