# K121363: Diowave Low Level Cold Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Technological Medical Advancments, Inc. (Tma)
- Decided: Nov 23, 2012 after 200 days
- Product code: ILY (Lamp, Infrared, Therapeutic Heating)
- Device class: 2
- Regulation: 21 CFR 890.5500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K242755: Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) (2025), 1 descendant of its own
- 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
- K151521: Phoenix Thera-Lase System (2015), 0 descendants of its own

## Recalls of this device
- Jan 9, 2026 · Class II · Z-2162-2026: Software update is needed for laser systems, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms, stiffness associated with minor arthritis, and to temporar

## Indications for use
The Diowave Laser System 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 stiffiess associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.

Source page: https://510kreport.com/device/K121363
Methodology: https://510kreport.com/methodology