# K961935: Sharplan Lasers, Inc. Silktouch CO2 Flash Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Sharplan Lasers, Inc.
- Decided: Nov 1, 1996 after 165 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Norcross Scientific SurgiScan CO2 Scanner: named in the summary without a submission number
- (no number) A-Z Surgical Super Punch: named in the summary without a submission number
- (no number) Robbins Acrotorque Hand Engine: named in the summary without a submission number

## Most influential descendants
- K980398: Kaplan Pendulaser 115 Surgical Laser with Optoscan II (1998), 0 descendants of its own
- K974633: Scantech Laser Scanner (1998), 0 descendants of its own

## Indications for use
It is indicated for soft tissue incision of recipient sites for laser assisted hair transplantation.

Source page: https://510kreport.com/device/K961935
Methodology: https://510kreport.com/methodology