# K981447: Dio-Light 60 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Nidek, Inc.
- Decided: Jun 5, 1998 after 44 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
No predicates in its family tree.
147 later devices descend from it; 3 cite it directly.
0 of 148 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cynosure’s Photogenica LPIR laser system: named in the summary without a submission number

## Most influential descendants
- K020071: Viridis Derma Laser (2002), 92 descendants of its own
- K091534: Lightlas Model 532 (2009), 72 descendants of its own
- K100558: Quanta Diode Laser System (2010), 68 descendants of its own
- K990119: Epi-Star Surgical Laser Syster (2000), 50 descendants of its own
- K013864: Modification to Epi-Star Surgical Laser System, M0DEL DS-60 (2002), 49 descendants of its own

## Indications for use
Treatment of vascular and pigmented lesions in Dermatology.

Source page: https://510kreport.com/device/K981447
Methodology: https://510kreport.com/methodology