Device class
Class II
Regulation 878.5400
Total clearances
14
2020-01-13 → 2026-05-04
Definition
What is Fat Reducing Low Level Laser
Non-invasive reduction in fat layer for body contouring
Classification details
Medical specialty
General, Plastic Surgery
Regulation number
878.5400
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Erchonia Corporation
|
5 |
1 |
2025-12-15 |
|
Shenzhen Kaiyan Medical Equipment Co., Ltd.
|
2 |
2 |
2026-05-04 |
|
Contour Research, LLC |
2 |
1 |
2026-02-13 |
|
Shenzhen Suyzeko Limited. |
1 |
1 |
2025-12-01 |
|
Biophotas, Inc. |
1 |
0 |
2023-11-21 |
|
Resurgeonz, LLC |
1 |
0 |
2022-03-11 |
|
IR Technology, LLC |
1 |
0 |
2020-08-19 |
|
Ward Photonics, LLC |
1 |
0 |
2020-12-18 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 96567 |
CPT
|
— |
Medium
|
Photochemotherapy/laser-assisted lipolysis; non-invasive fat reduction via light energy |
| 15877 |
CPT
|
— |
Low
|
Liposuction code; contextual if considered fat reduction procedure rather than pure device service |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-05-04 |
K260688 |
Shenzhen Kaiyan Medical Equipment Co., Ltd.
|
Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) |
| 2026-04-15 |
K260129 |
Shenzhen Kaiyan Medical Equipment Co., Ltd.
|
Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) |
| 2026-02-13 |
K243854 |
Contour Research, LLC
|
Contour Light (CL-100) |
| 2025-12-15 |
K252574 |
Erchonia Corporation
|
Erchonia CLX (Model # CFL) |
| 2025-12-01 |
K252786 |
Shenzhen Suyzeko Limited.
|
Led Light Phototherapy Bed (Pro 450/ GY-680A) |
| 2025-01-10 |
K243811 |
Erchonia Corporation
|
Erchonia Zerona® VZ8 |
| 2023-11-21 |
K232977 |
Biophotas, Inc.
|
Biophotas Celluma CONTOUR |
| 2023-07-21 |
K231474 |
Erchonia Corporation
|
Erchonia Violet ZERONA® Z6 OTC |
| 2022-03-24 |
K220519 |
Erchonia Corporation
|
Erchonia Zerona Z-Bed |
| 2022-03-11 |
K213534 |
Resurgeonz, LLC
|
PHantom Trilogy |
| 2021-05-19 |
K202955 |
Contour Research, LLC
|
Contour Light CL-100 |
| 2020-12-18 |
K202361 |
Ward Photonics, LLC
|
UltraSlim Digital, UltraSmooth Digital |
| 2020-08-19 |
K192275 |
IR Technology, LLC
|
invisa-RED ELITE |
| 2020-01-13 |
K192544 |
Erchonia Corporation
|
Erchonia Emerald |