# K970017: Nidek Cyberscan

- Pathway: 510(k) (Traditional)
- Applicant: Nidek, Inc.
- Decided: Mar 18, 1997 after 75 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: 1 generation back to K955734 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955734: Lasersonics Parascan Dosimeter Device, Heraeus Surgical, Inc. (1996) Summary page 1.

## Indications for use
The CyberScan Device is intended for use for all cleared Heraeus LaserSonics CO2 soft tissue surgical applications.(K955734)

Source page: https://510kreport.com/device/K970017
Methodology: https://510kreport.com/methodology