← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K963229 # SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERS (K963229) _Sharplan Lasers, Inc. · GEX · Nov 5, 1996 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K963229 ## Device Facts - **Applicant:** Sharplan Lasers, Inc. - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Nov 5, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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 • (201) 327-1666 • (800) 394-2000 • (201) 445-4048 fax {1} page 2 # 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. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K963229](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K963229) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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