# K982295: Nidek Lightscan

- Pathway: 510(k) (Traditional)
- Applicant: Nidek, Inc.
- Decided: Aug 6, 1998 after 36 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: 3 generations back to K955734 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971024: Softscan, Sahar Technologies, Inc. (1997) Summary page 1.

## Indications for use
The LightScan accessory device is intended to be used to manipulate and place a pulsed and/or CW laser beam for use in Dermatology for treatment of any soft tissue, including, ablation, vaporization and coagulation of soft tissue on the skin.

Source page: https://510kreport.com/device/K982295
Methodology: https://510kreport.com/methodology