# K070516: Powerlaser

- Pathway: 510(k) (Traditional)
- Applicant: Powermedic Aps
- Decided: Jul 2, 2007 after 130 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: 2 generations back to K010175 (2002). 3 ancestors in all.
63 later devices descend from it; 4 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030692: Power Laser 90, Andi Electromedical Aps (2003) Summary page 2.
- K040662: Vectra Genisys (Module & Transportable) and Intelect XT (Module & Transportable) Laser Systems, Chattanooga Group (2004) Summary page 2.

## Most influential descendants
- K083595: Ezlase (2009), 58 descendants of its own
- K121286: EPIC 10 (2012), 31 descendants of its own
- K123971: Cynosure 1064NM Diode Laser (2013), 25 descendants of its own
- K170500: SIROLaser Advance+ (2017), 21 descendants of its own
- K150724: SculpSure (2015), 21 descendants of its own

## Indications for use
The PowerL-aser is intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; the temporary relaxation of muscle and/or increased healing of wounds.

Source page: https://510kreport.com/device/K070516
Methodology: https://510kreport.com/methodology