# K964684: Softouch

- Pathway: 510(k) (Traditional)
- Applicant: Sahar Technologies, Inc.
- Decided: Feb 14, 1997 after 84 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.
6 later devices descend from it; 6 cite it directly.
0 of 9 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
- K980398: Kaplan Pendulaser 115 Surgical Laser with Optoscan II (1998), 0 descendants of its own
- K980784: Suretouch (1998), 0 descendants of its own
- K974633: Scantech Laser Scanner (1998), 0 descendants of its own
- K972028: Dermascan Surgical Laser Scanner (1997), 0 descendants of its own
- K971903: Scanning Device Accessory for Use with the CB Diode/532 ND:Yag Laser (1997), 0 descendants of its own

## Indications for use
@W&Wadmx&atmwv« large variable areas in a safe and homogeneous way. The SofTouch provides the ability to cover large and small areas of soft tissue while having perfect control of the emission placement and the emission reproducibility. The ability of the physician to identify the area to be treated by watching the aiming beam, while controlling the shape and the size that best fits the treated area enhances the precision and safety of the treatment. The timing of the emission placement on the tissue is done by the SofTouch hardware and software to avoid errors and to increase precision and homogeneity. SofTouch is a hand held device that is flexible enough to allow the physician the freedom to choose the area of treatment without being restricted by the system.

Source page: https://510kreport.com/device/K964684
Methodology: https://510kreport.com/methodology