SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERS

K963229 · Sharplan Lasers, Inc. · GEX · Nov 5, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K963229
• Device Name: SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERS
• Applicant: Sharplan Lasers, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sharplan Models 20c, 30c, and 40c CO2 Lasers are surgical lasers are medical devices which capable of incising soft tissue. They emit a treatment laser beam at a wavelength of 10.6 µm up to 40 watts and a 3 mWatt HeNe aiming beam. They are intended for soft tissue incision in ENT for the specific indication of Myringotomy/Tympanostomy.

Device Story

Sharplan Models 20c, 30c, and 40c CO2 lasers; surgical devices for soft tissue incision. Input: electrical power; Output: 10.6 µm CO2 treatment laser beam (up to 40W) and 3mW HeNe aiming beam. Used in ENT clinical settings by physicians. Device enables precise incision of tympanic membrane for myringotomy/tympanostomy. Clinical benefit: alternative to traditional scalpel-based myringotomy, providing controlled tissue incision.

Clinical Evidence

Clinical results from 80 patients across 2 sites provided, supplemented by historical data. Data supports safety and effectiveness for laser-assisted myringotomy/tympanostomy indication.

Technological Characteristics

CO2 laser system; 10.6 µm wavelength; up to 40W power output; 3mW HeNe aiming beam. Surgical laser for soft tissue incision.

Indications for Use

Indicated for soft tissue incision in ENT procedures, specifically for laser-assisted myringotomy/tympanostomy.

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

• Sharplan CO2 Lasers (intended for ENT use)
• ScalpelTEC, Inc. Myringotomy Safety Scalpel

Submission Summary (Full Text)

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NOV - 5 1996

SHARPLAN

LASERS, INC.

K 963229

# 510(k) Summary of Safety and Effectiveness
Sharplan Lasers, Inc. CO2 Laser Systems for Laser Assisted Myringotomy/Tympanostomy Indication

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 Sharplan CO2 Laser Systems for Laser Assisted Myringotomy/Tympanostomy Indication is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices which include the Sharplan CO2 Lasers which are intended for use in ENT and the ScalpelTEC, Inc. Myringotomy Safety Scalpel.

1. Sharplan Lasers, Inc.
1 Pearl Court
Allendale, NJ 07401
George J. Hattub, Director of Regulatory Affairs/Quality Assurance
August 16, 1996

2. Model: Sharplan Models 20c, 30c, and 40c CO2 Lasers

3. Predicate Devices: The Sharplan CO2 Lasers which are intended for use in ENT and the ScalpelTEC, Inc. Myringotomy Safety Scalpel.

4. Description: The Sharplan Models 20c, 30c, and 40c CO2 Lasers are surgical lasers are medical devices which capable of incising soft tissue. They emit a treatment laser beam at a wavelength of $10.6\,\mu\mathrm{m}$ up to 40 watts and a $3\,\mathrm{mWatt}\,\mathrm{HeNe}$ aiming beam.

5. The Sharplan Models 20c, 30c, and 40c (for this indication) are substantially equivalent to the following devices: The Sharplan CO2 Lasers which are intended for use in ENT and the ScalpelTEC, Inc. Myringotomy Safety Scalpel. They are intended for soft tissue incision in ENT for the specific indication of Myringotomy/Tympanostomy.

Clinical results from 80 patients, which were obtained at 2 sites, were presented as part of this $510(k)$ submission, along with historical data, in order to demonstrate the safety and effectiveness of the device.

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

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# 510(k) Summary of Safety and Effectiveness
Sharplan Lasers, Inc. CO2 Laser Systems for Laser Assisted Myringotomy/Tympanostomy Indication
(continued)

6. From a design and clinical perspective, the predicate and candidate laser devices, are of the same technology (they are identical), and have the same intended use. The other predicate device, which is a surgical scalpel, has the same intended use as the candidate device. Based upon an analysis of the overall performance characteristics for the devices, Sharplan Lasers, Inc. believes that no significant differences exist. Furthermore, this expanded indication should not raises any concerns regarding the safety or effectiveness of the Sharplan Lasers, Inc. CO2 Laser Systems for a Laser Assisted Myringotomy/Tympanostomy Indication

**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.