SHARPLAN LASERS, INC. SILKTOUCH XJ SCANNER

K960820 · Sharplan Lasers, Inc. · GEX · May 10, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K960820
• Device Name: SHARPLAN LASERS, INC. SILKTOUCH XJ SCANNER
• Applicant: Sharplan Lasers, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Motorized laser beam deflection system; attaches to Sharplan CO2 laser articulating arm. Redirects focused laser beam via moving mirrors within specified scan patterns. Limits tissue exposure time while maintaining power density for vaporization at low average power. Includes CO2 handpiece and LCD control panel for pattern/parameter selection. Used in clinical settings by surgeons. Does not override host laser safety mechanisms. Benefits include controlled tissue ablation/vaporization similar to manual scanning techniques.

Clinical Evidence

No clinical data presented. Substantial equivalence based on physical testing of device function and performance compared to predicates.

Technological Characteristics

Motorized laser beam deflection system; utilizes moving mirrors to redirect CO2 laser beam. Includes LCD control panel interface. Compatible with Sharplan CO2 laser models 60, 80, and 150 xj. Attaches to articulating arm.

Indications for Use

Indicated for soft tissue incision, excision, coagulation, vaporization, and ablation across general/thoracic surgery, neurosurgery, otolaryngology, dental surgery (soft tissue), gynecology, podiatry, plastic surgery/dermatology, and genito-urinary surgery.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Coherent Computerized Pattern Generator
• Sharplan SwiftLase (aka SilkTouch) CO2 Flashscanner (K946304, K941312)

Submission Summary (Full Text)

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SHARPLAN LASERS, INC.
K96080
MAY 10 1996

# 510(k) Summary of Safety and Effectiveness
## Sharplan Lasers, Inc. Silktouch XJ Scanner CO2 Laser Accessory

In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

The safety and effectiveness of the Sharplan Lasers, Inc. Silktouch XJ Scanner is based on a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices which include the Coherent Computerized Pattern Generator and the Sharplan SwiftLase (aka SilkTouch) CO2 Flashscanner.

1. Sharplan Lasers, Inc.
1 Pearl Court
Allendale, NJ 07401
George J. Hattub, Director of Regulatory Affairs
Updated: October, 1995.
1-800-394-2000, ext. 531

2. Model: Sharplan Lasers, Inc. Silktouch XJ Scanner CO2 Laser Accessory

3. Predicate Devices: The Coherent Computerized Pattern Generator and the Sharplan SwiftLase (aka SilkTouch) Flashscanner.

4. Description: The Sharplan Lasers, Inc. Silktouch XJ Scanner CO2 Laser Accessory is a motorized, laser beam deflection system that is attached to a Sharplan CO2 laser articulating arm. The device redirects a focused laser beam from moving mirrors, within a specified pattern scan area. Similar to the common surgeon’s technique of manually scanning a focused beam over a treatment area, the constantly moving beam of the Silktouch XJ Scanner limits the time of laser exposure on tissue while providing sufficient power density for tissue vaporization at low average power levels. This device features a CO2 handpiece and LCD control panel interface which allows the operator to select or change the various patterns and treatment parameters. This accessory does not defeat or over-ride the safety or control mechanisms which are integral to CO2 laser system.

5. The Sharplan Lasers, Inc. Silktouch XJ Scanner Accessory is substantially equivalent to the following devices: Coherent Computerized Pattern Generator and the Sharplan SwiftLase (aka SilkTouch) Scanner ( K946304 and K941312, respectively). It is a CO2 accessory for a Sharplan Laser (models 60, 80, and 150 xj). 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.

No new indications were sought in this premarket notification and no clinical data was presented.

1 Pearl Court • Allendale, NJ 07401 • [phone] • [phone] • [phone] fax

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# 510(k) Summary of Safety and Effectiveness (continued)
Sharplan Lasers, Inc. Silktouch XJ Scanner CO2 Laser Accessory

6. From a clinical performance perspective, the aforementioned devices produce a similar therapeutic output in terms of laser spot size and patterns. Regarding the technological characteristics, while are not identical, physical testing of the device has demonstrated that it is similar both in function and performance to its predicate devices. Sharplan Lasers, Inc. believes that none of the modifications made to the device raise any issues pertaining to its safety or efficacy.

**Advisory:** This information was prepared for the sole purpose of compliance with the Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or death to patients due to operator error or in procedures requiring a high degree of skill.