# K242755: Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)

- Pathway: 510(k) (Traditional)
- Applicant: Gigaalaser Company, Ltd.
- Decided: May 19, 2025 after 249 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: 22 generations back to K943450 (1995). 241 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 243 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142078: Velasii Therapy Laser System, Aspen Laser Systems, LLC (2014) Summary page 6.
- K150138: Aspen Laser Systems Therapy Laser System, Aspen Laser Systems, LLC (2015) Summary page 6.
- K121363: Diowave Low Level Cold Laser System, Technological Medical Advancments, Inc. (Tma) (2012) Summary page 6.
- K230047: Medical Diode Laser Systems, Gigaalaser Company, Ltd. (2024) Summary page 7.

## Most influential descendants
- K253965: CureLight Medical Diode Laser Systems (CureLight F2-A15;  CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.) (2026), 0 descendants of its own

## Indications for use
The Medical Diode Laser Systems, include model: VELASⅡ-30A, GBOX-15AB, GBOX-20B, CHEESEⅡ-10B 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 Medical Diode Laser Systems, model: VELASⅡ-30B is 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 Medical Diode Laser Systems, model: VELASⅡ-30B is 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/K242755
Methodology: https://510kreport.com/methodology