# K083595: Ezlase

- Pathway: 510(k) (Traditional)
- Applicant: Biolase Technology, Inc.
- Decided: Apr 14, 2009 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: 9 generations back to K910422 (1992). 58 ancestors in all.
58 later devices descend from it; 2 cite it directly.
0 of 117 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070516: Powerlaser, Powermedic Aps (2007) Summary page 2.
- K070024: Thor VR Single Diode Laser Treatment Probe, Model 200 MW Single VR Diode Probe, Thor International (2007) Summary page 2.
- K080318: Alma Laser Nir Module, Alma Lasers, Ltd. (2008) Summary page 2.
- K082707: Medx LPT 200 Tethered Laser & Medx LPS 200 (Oralase) Portable Laser, Medx Electronics, Inc. (2008) Summary page 2.

## Most influential descendants
- 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
- K150230: SculpSure (2015), 21 descendants of its own

## Indications for use
The ezlase diode system emits energy in the 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, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

Source page: https://510kreport.com/device/K083595
Methodology: https://510kreport.com/methodology