# K962242: Surescan

- Pathway: 510(k) (Traditional)
- Applicant: Clinicon Corp.
- Decided: Sep 3, 1996 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: 1 generation back to K955734 (1996). 1 ancestor in all.
11 later devices descend from it; 6 cite it directly.
0 of 13 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.
- (no number) Coherent Computerized Pattern Generator: named in the summary without a submission number

## Most influential descendants
- K964684: Softouch (1997), 6 descendants of its own
- K971024: Softscan (1997), 3 descendants of its own
- K021650: Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos Laser (2002), 0 descendants of its own
- K980398: Kaplan Pendulaser 115 Surgical Laser with Optoscan II (1998), 0 descendants of its own
- K982295: Nidek Lightscan (1998), 0 descendants of its own

## Indications for use
SureScan may be used for a varety of soft tissue ablation procedures where precise removal is required to minimize damage to adjacent or underlying tissue layers. SureScan employs a microprocessor controlled, mirror system for scanning the laser beam. Using advanced software control, SureScan juxtaposes laser beam spots with precisely controlled amounts of spatial overlap and time between overlap spots. Highly controlled tissue ablation is achieved with minimal thermal injury. The microprocessor controlled fail-safe system eliminates potential hazards because the operation is controlled via an existing laser footswitch, so there is no interference with the internal electronics or workings of the laser. SureScan allows for realignment of a laser beam due to an out of calibration articulated arm. As a result, the physician is always assured of optimum beam quality and mode as it exits the SureScan Device. If the beam characteristics of the laser do not meet the control standards of the SureScan system, an audible warning is provided to the operator and the laser footswitch rendered inoperative.

Source page: https://510kreport.com/device/K962242
Methodology: https://510kreport.com/methodology