# K131113: Biophotas Celluma

- Pathway: 510(k) (Traditional)
- Applicant: Biophotas, Inc.
- Decided: Jan 15, 2014 after 268 days
- Product code: ILY (Lamp, Infrared, Therapeutic Heating)
- Device class: 2
- Regulation: 21 CFR 890.5500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K943450 (1995). 132 ancestors in all.
55 later devices descend from it; 3 cite it directly.
0 of 188 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122237: Biophotas Lifelight, Biophotas, Inc. (2013) Summary page 1.

## Most influential descendants
- K152280: BioPhotas Celluma3 (2016), 49 descendants of its own
- K200983: Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine (2021), 46 descendants of its own
- K223544: LED light therapy mask (FM-01, FM-02, FM-03) (2023), 39 descendants of its own
- K241857: LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) (2024), 21 descendants of its own
- K242700: Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) (2024), 6 descendants of its own

## Indications for use
The Biophotas Celluma® device is intended to deliver heat in the IR 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 blue spectrum is intended to reduce mild to moderate inflammatory acne vulgaris.

Source page: https://510kreport.com/device/K131113
Methodology: https://510kreport.com/methodology