# K960521: Sharplan Lasers, Inc. Silktouch Flash Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Sharplan Lasers, Inc.
- Decided: Apr 26, 1996 after 81 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 K936109 (1994). 2 ancestors in all.
677 later devices descend from it; 5 cite it directly.
0 of 680 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K936109: Sharplan Model 1120 CO2 Surgical Laser, Sharplan Lasers, Inc. (1994) Summary page 1.
- K941312: Sharplan Swiftlase 765/766/767 Flashscan, Sharplan Lasers, Inc. (1994) Summary page 1.

## Most influential descendants
- K963339: Coherent Ultrapulse CO2 Surgical Lasers (1997), 675 descendants of its own
- K974789: Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L (1998), 653 descendants of its own
- K022060: Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories (2002), 376 descendants of its own
- K990947: Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND: Yag Surgical Lasers and  Delivery (1999), 350 descendants of its own
- K011703: Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices (2001), 342 descendants of its own

## Indications for use
It is indicated for incision/excision, ablation/vaporization, coagulation, and debridement of soft tissue in Plastic Surgery/Dermatology. Plastic Surgery/Dermatology procedures encountered are: laser skin resurfacing/dermabrasion, blepharoplasty, rhinophyma, squamous cell carcinoma, buccal hemangioma, telangjectasis, the treatment of wrinkles or rhytides, and scar revision.

Source page: https://510kreport.com/device/K960521
Methodology: https://510kreport.com/methodology