# K061656: Laser-D68

- Pathway: 510(k) (Traditional)
- Applicant: Laser Pain Clinics LP
- Decided: Dec 15, 2006 after 189 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K875052 (1988). 27 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050070: K-Laser, Models 3,4,4D,6D, Eltech S.R.L (2005) Summary page 1.
- K053473: Maestro MDTL Laser System, Advanced Medical Technologies, Inc. (2006) Summary page 1.

## Most influential descendants
- K120604: K-Laser (2012), 4 descendants of its own
- K171087: AXON IR Heat Lamp (2017), 0 descendants of its own
- K161198: Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 (2016), 0 descendants of its own
- K160947: LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System (2016), 0 descendants of its own
- K151521: Phoenix Thera-Lase System (2015), 0 descendants of its own

## Indications for use
Laser-D68 System provides visible red and infrared therapy to provide topical heating for the temporary: * Increase in local blood circulation * Relief of minor muscles and joint aches, pains and stiffness * Relaxation of muscles * Relief of muscle spasms * Relief of minor pain and stiffness associated with arthritis

Source page: https://510kreport.com/device/K061656
Methodology: https://510kreport.com/methodology