# K152280: BioPhotas Celluma3

- Pathway: 510(k) (Traditional)
- Applicant: Biophotas, Inc.
- Decided: Mar 2, 2016 after 203 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: 13 generations back to K943450 (1995). 134 ancestors in all.
49 later devices descend from it; 3 cite it directly.
0 of 184 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131113: Biophotas Celluma, Biophotas, Inc. (2014) Summary page 4.
- K083183: Aklarus Phototherapy System, Hill Laboratories Co. (2009) Summary page 4.

## Most influential descendants
- 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
- K202028: dermalux Flex MD (2020), 5 descendants of its own

## Indications for use
The BioPhotas Celluma3 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 light is intended to reduce mild to moderate inflammatory acne vulgaris. The Celluma3 is intended to emit energy in the red and infrared spectrum for use in dermatology for the treatment of periorbital wrinkles.

Source page: https://510kreport.com/device/K152280
Methodology: https://510kreport.com/methodology