# K980201: Dio-Light Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Nidek, Inc.
- Decided: Mar 16, 1998 after 55 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 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 Photogenica LPIR laser system: named in the summary without a submission number

## Most influential descendants
- K032397: Dual Yellow Laser, Model Dual Yellow D10B (2004), 2 descendants of its own
- K132976: Advatx (2014), 1 descendant of its own
- K250189: AdvaTx (2025), 0 descendants of its own

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

Source page: https://510kreport.com/device/K980201
Methodology: https://510kreport.com/methodology