Biophotas Celluma CONTOUR
FDA 510(k) K232977 · Biophotas, Inc.
510(k) numberK232977
Submission
- Device name
- Biophotas Celluma CONTOUR
- Applicant
- Biophotas, Inc.
Tustin, CA, US - Received
- September 21, 2023
- Decision date
- November 21, 2023
- 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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| K260129 | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )OLI · Traditional | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 04/15/2026SE |
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| 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 |
| 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 |
|---|---|---|
| K211038 | Biophotas Celluma RESTOREOAP · Traditional | 06/29/2021SE |
| K171323 | Biophotas CELLUMA3OHS · Traditional | 09/01/2017SE |
| K152280 | BioPhotas Celluma3ILY · Traditional | 03/02/2016SE |
| K131113 | Biophotas CellumaILY · Traditional | 01/15/2014SE |
| K122237 | Biophotas LifelightILY · Traditional | 01/03/2013SE |
Questions and answers
When was Biophotas Celluma CONTOUR cleared by the FDA?
Biophotas Celluma CONTOUR (K232977) received a 510(k) decision of Substantially Equivalent on November 21, 2023, 61 days after the submission was received.
What is the product code of K232977?
The FDA product code is OLI – Fat Reducing Low Level Laser, a Class II (moderate risk) device regulated under 21 CFR 878.5400.