# K980784: Suretouch

- Pathway: 510(k) (Traditional)
- Applicant: Sahar Technologies, Inc.
- Decided: Apr 29, 1998 after 58 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 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.
- K964684: Softouch, Sahar Technologies, Inc. (1997) Summary page 1.
- K962242: Surescan, Clinicon Corp. (1996) Summary page 1.
- K955734: Lasersonics Parascan Dosimeter Device, Heraeus Surgical, Inc. (1996) Summary page 1.

## Indications for use
SureTouch 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/K980784
Methodology: https://510kreport.com/methodology