← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K962446 # SHARPLAN RUBY LASER SYSTEM (K962446) _Sharplan Lasers, Inc. · GEX · Mar 7, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K962446 ## Device Facts - **Applicant:** Sharplan Lasers, Inc. - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Mar 7, 1997 - **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 Lasers, Inc. Ruby Laser System is substantially equivalent to the following devices: the Sharplan Ruby Laser, the ThermoLase LT-100 Q-Switched Nd:YAG Laser, the American Hair Removal System, and the Spectrum EpiLaser (Ruby) System (K961279, K950019, K892514, and K955612 respectively). It is intended for use in dermatology for the removal of unwanted dark body hair. ## Device Story Surgical laser system; delivers pulsed (Q-Switched or Free Running) 694.3 nm laser energy via articulated arm. Physician-operated in clinical dermatology setting; uses 633 nm HeNe aiming beam for guidance; foot switch activation. Device targets hair follicles to achieve hair removal. Clinical benefit: removal of unwanted dark body hair. ## Clinical Evidence Clinical data presented for 31 patients with 3-month follow-up period to demonstrate safety and efficacy for hair removal. ## Technological Characteristics Ruby laser source; 694.3 nm wavelength; pulsed (Q-Switched or Free Running) output; articulated arm beam delivery; 633 nm HeNe aiming beam; foot switch control. ## 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 Ruby Laser - ThermoLase LT-100 Q-Switched Nd:YAG Laser ([K950019](/device/K950019.md)) - American Hair Removal System ([K892514](/device/K892514.md)) - Spectrum EpiLaser (Ruby) System ([K961279](/device/K961279.md), [K955612](/device/K955612.md)) ## 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} MAR - 7 1997 K962446 # 510(k) Summary of Safety and Effectiveness ## Sharplan Lasers, Inc. Ruby Laser System 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. Ruby Laser System is based on a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices which include the Sharplan Ruby Laser, the ThermoLase LT-100 Q-Switched Nd:YAG Laser, the American Hair Removal System, and the Spectrum EpiLaser (Ruby) System. ## 1. Firm: Sharplan Lasers, Inc. 1 Pearl Court Allendale, NJ 07401 December 6, 1996 George J. Hattub, Director of Regulatory Affairs 1-800-394-2000, ext. 531 ## 2. Model: Sharplan Lasers, Inc. Ruby Laser System (for Hair Removal Indication) ## 3. Predicate Devices: The Sharplan Ruby Laser, the ThermoLase LT-100 Q-Switched Nd:YAG Laser, the American Hair Removal System, and the Spectrum EpiLaser (Ruby) System. ## 4. Description: The Sharplan Ruby Laser System is a surgical laser which is capable of providing pulsed (Q-Switched or Free Running) laser energy of a 694.3 nm wavelength through an articulated arm beam delivery system. While observing and directing the aiming beam (633 nm, HeNe), the treatment beam is administered by the physician through a foot switch. ## 5. Intended Use: The Sharplan Lasers, Inc. Ruby Laser System is substantially equivalent to the following devices: the Sharplan Ruby Laser, the ThermoLase LT-100 Q-Switched Nd:YAG Laser, the American Hair Removal System, and the Spectrum EpiLaser (Ruby) System (K961279, K950019, K892514, and K955612 respectively). It is intended for use in dermatology for the removal of unwanted dark body hair. Clinical data on 31 patients with a 3 month follow-up period was presented in order to demonstrate the safety and efficacy of the device. Revised December 6, 1996 {1} # 510(k) Summary of Safety and Effectiveness (continued) ## Sharplan Lasers, Inc. Ruby Laser System ### 6. Intended Use & Technological Characteristics From a clinical performance and intended use perspective, two of the predicate devices (the ThermoLase LT 100 and the American Hair Removal System) and the candidate device, (the Sharplan Ruby Laser System) produces a similar result which is the removal of unwanted body hair. In terms of functioning characteristics, for one of the predicate devices (the Spectrum EpiLaser), and the Sharplan Ruby Laser System are of the same technology. Furthermore, they have the same operating principle, and their performance characteristics are similar. Sharplan Lasers, Inc. believes that the differences between the aforementioned devices do not raise any issues pertaining to 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. Revised December 6, 1996 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K962446](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K962446) **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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