← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K964353 # CYBERLASE CO2 LASER SYSTEM (K964353) _Nidek, Inc. · GEX · Feb 28, 1997 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K964353 ## Device Facts - **Applicant:** Nidek, Inc. - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Feb 28, 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 CyberLase CO2 Laser Systems are intended for the surgical removal (i.e., excision, incision, cutting, ablation, coagulation, homeostasis or vaporization) of soft tissue in all surgical applications with the use of wavelength of 10.6µm. Areas to be covered are: Head and Neck(ENT) including Uvulopalatoplasty, Neurosurgery, General / Plastic Surgery, Dermatology, Oncology, Obstetrics/Gynecology, Orthopedics, Polymethylmethacrylate(PMMA) Removal during Revision Arthroplasty Procedures, and Thoracoscopic applications. ## Device Story CyberLase CO2 Laser System; emits 10.6µm wavelength laser energy for soft tissue surgery. Used by surgeons in OR/clinical settings for excision, incision, ablation, coagulation, and vaporization. Device provides precise tissue interaction for various specialties including ENT, neurosurgery, and orthopedics (e.g., PMMA removal). Physician operates laser via delivery system to target tissue; thermal energy achieves desired surgical effect. Benefits include controlled tissue removal and hemostasis. ## Clinical Evidence No clinical data provided; substantial equivalence based on technological and intended use comparison to predicate. ## Technological Characteristics CO2 laser system; 10.6µm wavelength; complies with 21 CFR 1040.10 and 1040.11. Class II device (79GEX). ## 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 - Heraeus LaserSonics Paragon Laser System ## 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} K964353 SUMMARY OF SAFETY AND EFFECTIVENESS NIDEK CyberLase CO2 LASER SYSTEMS FEB 28 1997 REGULATORY AUTHORITY: Safe Medical Devices Act of 1990, 21CFR 807.92 COMPANY NAME/CONTACT: Ken Kato Vice President 47651 Westinghouse Drive Fremont, CA. 94539-7474 Phone: (510)226-5700 Fax: (510)226-5750 DEVICE TRADE NAME: CyberLase CO2 Laser System DEVICE COMMON NAME: CO2 Surgical Laser System DEVICE CLASSIFICATION: CO2 laser system have been classified as Class II (79GEX) medical devices by the OB/GYN, General, Plastic Surgery and ENT Device Advisory Panels. To the best of our knowledge, CO2 laser delivery system has not been classified. PERFORMANCE STANDARDS: The laser systems manufactured by Nidek Inc. comply with 21 CFR 1040.10 and 1040.11, FDA regulations for medical laser products, as applicable Nidek Inc. is unaware of any specific standards for CO2 laser delivery systems. {1} # INDICATIONS FOR USE STATEMENT: The CyberLase CO2 Laser Systems are intended for the surgical removal (i.e., excision, incision, cutting, ablation, coagulation, homeostasis or vaporization) of soft tissue in all surgical applications with the use of wavelength of 10.6µm. Areas to be covered are: Head and Neck(ENT) including Uvulopalatoplasty, Neurosurgery, General / Plastic Surgery, Dermatology, Oncology, Obstetrics/Gynecology, Orthopedics, Polymethylmethacrylate(PMMA) Removal during Revision Arthroplasty Procedures, and Thoracoscopic applications. # COMPARISON WITH PREDICATE DEVICE: The Nidek CO2 Laser system is substantially equivalent to the Heraeus LaserSonics Paragon Laser System. The risks and benefits of the Nidek CyberLase CO2 Laser System is comparable to the predicate device when used for similar clinical applications. Since the Nidek CyberLase CO2 Laser System is substantially equivalent with respect to indications for use, materials, method of operation and physical construction to the predicate device, we believe it clearly meets the requirement for substantial equivalence according to Section 510(k) guidelines. Safety and effectiveness are reasonably assured, therefore justifying 510(k) clearance for commercial sale. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K964353](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX/K964353) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com