# K253965: CureLight Medical Diode Laser Systems (CureLight F2-A15;  CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)

- Pathway: 510(k) (Traditional)
- Applicant: Wuhan PHOMED Technology Company, Ltd.
- Decided: Mar 19, 2026 after 98 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: 23 generations back to K943450 (1995). 242 ancestors in all.
No later device cites it as a predicate yet.
0 of 243 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242755: Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B), Gigaalaser Company, Ltd. (2025) Summary page 6.
- K121363: Diowave Low Level Cold Laser System, Technological Medical Advancments, Inc. (Tma) (2012) Summary page 6.

## Indications for use
(1) The CureLight Medical Diode Laser Systems, include model: CureLight F2-A15 and CureLight F2-A30, are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation. (2) The CureLight Medical Diode Laser Systems, model: CureLight F2-B15, CurelLight F2-B30, CureLight F3-AB30 and CurelLight F3-AB60 are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation. The CureLight Medical Diode Laser Systems, model: CurelLight F2-B15, CurelLight F2-B30, CureLight F3-AB30 and CureLight F3-AB60 are also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

Source page: https://510kreport.com/device/K253965
Methodology: https://510kreport.com/methodology