# K123971: Cynosure 1064NM Diode Laser

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: May 2, 2013 after 127 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: 16 generations back to K943450 (1995). 101 ancestors in all.
25 later devices descend from it; 4 cite it directly.
0 of 127 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083595: Ezlase, Biolase Technology, Inc. (2009) Summary page 1.
- K051537: Hilt Family Laser: Hilt I, Hilt II, Hilt Iii, Cynosure, Inc. (2005) Summary page 2.
- K100230: Smoothshapes System, 11318-120V, 11319-230V, Eleme Medical, Inc. (2010) Summary page 2.

## Most influential descendants
- K150724: SculpSure (2015), 21 descendants of its own
- K150230: SculpSure (2015), 21 descendants of its own
- K160470: SculpSure (2016), 20 descendants of its own
- K171111: Sculpsure (2017), 10 descendants of its own
- K171992: SculpSure (2017), 8 descendants of its own

## Indications for use
The Cynosure 1064nm Diode Laser Device is intended to provide heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.

Source page: https://510kreport.com/device/K123971
Methodology: https://510kreport.com/methodology