# K971024: Softscan

- Pathway: 510(k) (Traditional)
- Applicant: Sahar Technologies, Inc.
- Decided: Jun 17, 1997 after 89 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 K955734 (1996). 2 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962242: Surescan, Clinicon Corp. (1996) Summary page 1.
- K955734: Lasersonics Parascan Dosimeter Device, Heraeus Surgical, Inc. (1996) Summary page 1.

## Most influential descendants
- K021650: Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos Laser (2002), 0 descendants of its own
- K982295: Nidek Lightscan (1998), 0 descendants of its own
- K980784: Suretouch (1998), 0 descendants of its own

## Indications for use
SoftScan will 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/K971024
Methodology: https://510kreport.com/methodology