SHARPLAN LASERS, INC. SILKTOUCH FLASH SCANNER

K960521 · Sharplan Lasers, Inc. · GEX · Apr 26, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K960521
• Device Name: SHARPLAN LASERS, INC. SILKTOUCH FLASH SCANNER
• Applicant: Sharplan Lasers, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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, telangiectasis, the treatment of wrinkles or rhytides, and scar revision.

Device Story

SilkTouch CO2 Flash Scanner Accessory; motorized laser beam deflection system; attaches to CO2 laser articulating arm. Redirects focused laser beam via moving mirrors within specified pattern scan area; limits laser exposure time on tissue; provides power density for vaporization at low average power. Controls allow scan area variation (0.9 to 9 mm); scan duration 0.05 - 0.45 seconds. Used with CO2 handpieces or micromanipulators in clinical settings by surgeons. When off, laser functions normally for incision or manual scanning. Benefits include controlled tissue vaporization; reduced thermal damage risk compared to manual scanning.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological similarities and performance of same functions as predicate devices.

Technological Characteristics

Motorized laser beam deflection system; moving mirrors; attaches to CO2 laser articulating arm. Scan area: 0.9-9 mm; scan time: 0.05-0.45 seconds. Compatible with CO2 handpieces/micromanipulators.

Indications for Use

Indicated for incision, excision, ablation, vaporization, coagulation, and debridement of soft tissue in plastic surgery and dermatology, including skin resurfacing, blepharoplasty, rhinophyma, squamous cell carcinoma, buccal hemangioma, telangiectasis, wrinkle treatment, and scar revision.

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

• Robbins Acrotorque & Bell Hand Engines
• Sharplan Model 1120 CO2 Surgical Laser
• Sharplan Lasers, Inc. SwiftLase CO2 Flash Scanner Accessory (aka SilkTouch) (K936109, K941312)

Submission Summary (Full Text)

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K960521 APR 26 1996

# 510(k) Summary of Safety and Effectiveness
## Sharplan Lasers, Inc. SilkTouch CO2 Flash Scanner 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 CO2 Flash Scanner is based on a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices which include the Robbins Acrotorque & Bell Hand Engines, the Sharplan Model 1120 CO2 Surgical Laser, and the Sharplan Lasers, Inc SwiftLase CO2 Flash Scanner Accessory (aka SilkTouch).

1. Sharplan Lasers, Inc.
1 Pearl Court
Allendale, NJ 07401
George J. Hattub, Director of Regulatory Affairs
April 4, 1996
1-800-394-2000, ext. 531

2. Model: Sharplan Lasers, Inc. SilkTouch CO2 Flash Scanner Accessory

3. Predicate Devices: The Robbins Acrotorque & Bell Hand Engines, the Sharplan Model 1120 CO2 Surgical Laser, and the Sharplan Lasers, Inc. SwiftLase CO2 Flash Scanner Accessory (aka SilkTouch).

4. Description: The Sharplan Lasers, Inc. SilkTouch CO2 Flash Scanner Accessory is a motorized, laser beam deflection system that is attached to a CO2 laser articulating arm. The device redirects a focused laser beam through 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 Flash Scanner limits the time of laser exposure on tissue while providing sufficient power density for tissue vaporization at low average power levels. The SilkTouch Flash Scanner has controls for varying the scanned area from 0.9 to 9 mm and completes the scan within 0.05 - 0.45 seconds. This device is used with CO2 handpieces or micromanipulators. When the unit is turned off, the connected laser operates to its specifications and allows incision or manual scanning for vaporization purposes.

5. The Sharplan Lasers, Inc. SilkTouch CO2 Flash Scanner Accessory is substantially equivalent to the following devices: The Robbins Acrotorque & Bell Hand Engines, the Sharplan Model 1120 CO2 Surgical Laser, and the Sharplan SwiftLase CO2 Flash Scanner Accessory (aka SilkTouch) (preamended, K936109, K941312, and K936109, respectively). 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, telangiectasis, the treatment of wrinkles or rhytides, and scar revision.

REVISED APRIL 4, 1996

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# 510(k) Summary of Safety and Effectiveness (continued)
## Sharplan Lasers, Inc. SilkTouch CO₂ Flash Scanner Accessory

6. From a clinical performance perspective, the aforementioned devices while are not identical, perform the same function for the same indications. Regarding the technological similarities; while two of the predicated devices are of the same photonic technology with minor differences, the non-laser device relies upon a mechanical technology to achieve its therapeutic effect. Based upon the clinical information submitted, Sharplan Lasers, Inc. believes that the expanded indications for this device raises no safety or efficacy concerns.

**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.

REVISED APRIL 4, 1993