Contour Light CL-100
FDA 510(k) K202955 · Contour Research, LLC
510(k) numberK202955
Submission
- Device name
- Contour Light CL-100
- Applicant
- Contour Research, LLC
Reno, NV, US - Received
- September 30, 2020
- Decision date
- May 19, 2021
- 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
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260688 | Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)OLI · Traditional | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 05/04/2026SE |
| 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 |
More from Resurgeonz, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K243854 | Contour Light (CL-100)OLI · Special | 02/13/2026SE |
Questions and answers
When was Contour Light CL-100 cleared by the FDA?
Contour Light CL-100 (K202955) received a 510(k) decision of Substantially Equivalent on May 19, 2021, 231 days after the submission was received.
What is the product code of K202955?
The FDA product code is OLI – Fat Reducing Low Level Laser, a Class II (moderate risk) device regulated under 21 CFR 878.5400.