# K232977: Biophotas Celluma CONTOUR

- Pathway: 510(k) (Traditional)
- Applicant: Biophotas, Inc.
- Decided: Nov 21, 2023 after 61 days
- Product code: OLI (Fat Reducing Low Level Laser)
- Device class: 2
- Regulation: 21 CFR 878.5400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K943450 (1995). 171 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 177 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202955: Contour Light CL-100, Contour Research, LLC (2021) Summary page 5.
- K171323: Biophotas CELLUMA3, Biophotas, Inc. (2017) Summary page 5.
- K131113: Biophotas Celluma, Biophotas, Inc. (2014) Summary page 5.

## Most influential descendants
- K260129: Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) (2026), 1 descendant of its own
- K241947: EnergyLounger (TY-01) (2025), 1 descendant of its own
- K260715: CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) (2026), 0 descendants of its own
- K260688: Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) (2026), 0 descendants of its own
- K251781: Kala Mini 2.0 (Kala-04) (2025), 0 descendants of its own

## Indications for use
The BIOPHOTAS Celluma CONTOUR is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. The BIOPHOTAS Celluma CONTOUR is intended to deliver heat in the near infra-red 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. The BioPhotas Celluma CONTOUR is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of full-face wrinkles.

Source page: https://510kreport.com/device/K232977
Methodology: https://510kreport.com/methodology