# K964074: Diolite 532

- Pathway: 510(k) (Traditional)
- Applicant: Iriderm Div.
- Decided: Apr 1, 1997 after 172 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: 2 generations back to K933880 (1994). 5 ancestors in all.
307 later devices descend from it; 8 cite it directly.
0 of 313 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954905: CB Diode/532 Laser System, Continuum Biomedical, Inc. (1996) Summary page 1.
- K951034: Aura Laser System, Laserscope (1995) Summary page 1.
- K883541: Metalaser Vasculase, Metatech Corp. (1988) Summary page 1.
- K903883: Vasculase (R) Copper Vapor Laser Syst, Pigment Les, Metatech Corp. (1990) Summary page 1.

## Most influential descendants
- K083899: Revlite Q-Switched ND:Yag Laser System (2009), 198 descendants of its own
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own
- K103118: Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor (2010), 92 descendants of its own
- K020071: Viridis Derma Laser (2002), 92 descendants of its own
- K121346: Picosure Workstation (2012), 87 descendants of its own

## Indications for use
The DioLite 532 is a semiconductor-based laser system which delivers 532 nm laser light intended to be used for the photocoagulation of vascular and pigmented skin lesions.

Source page: https://510kreport.com/device/K964074
Methodology: https://510kreport.com/methodology