# K960820: Sharplan Lasers, Inc. Silktouch XJ Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Sharplan Lasers, Inc.
- Decided: May 10, 1996 after 71 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 K941312 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946304: Coherent Family of CO2 Surgical Laser Scanner Handpieces, Lumenis, Inc. (1995) Summary page 1.
- K941312: Sharplan Swiftlase 765/766/767 Flashscan, Sharplan Lasers, Inc. (1994) Summary page 1.

## Most influential descendants
- K974633: Scantech Laser Scanner (1998), 0 descendants of its own

## Indications for use
It is indicated for soft tissue incision, excision, coagulation, vaporization, and ablation for the following indications: General/Thoracic Surgery, Neurosurgery, Otolaryngology, Dental Surgery (soft tissue only), Gynecology, Podiatry, Plastic Surgery/Dermatology. and Genito-Urinary Surgery.

Source page: https://510kreport.com/device/K960820
Methodology: https://510kreport.com/methodology