Who is the manufacturer of CYBERLASE CO2 LASER SYSTEM?

Nidek, Inc. filed the 510(k) submission for CYBERLASE CO2 LASER SYSTEM (K964353).

What is the FDA product code for CYBERLASE CO2 LASER SYSTEM?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for CYBERLASE CO2 LASER SYSTEM?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CYBERLASE CO2 LASER SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CYBERLASE CO2 LASER SYSTEM

K964353 · Nidek, Inc. · GEX · Feb 28, 1997 · General, Plastic Surgery

Device Facts

Record ID	K964353
Device Name	CYBERLASE CO2 LASER SYSTEM
Applicant	Nidek, Inc.
Product Code	GEX · General, Plastic Surgery
Decision Date	Feb 28, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
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).

Indications for Use

Indicated for surgical removal (excision, incision, cutting, ablation, coagulation, homeostasis, vaporization) of soft tissue in patients requiring ENT, neurosurgical, general/plastic surgery, dermatological, oncological, OB/GYN, orthopedic, or thoracoscopic procedures.

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

Heraeus LaserSonics Paragon Laser System

Related Devices

K030147 — LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS · Lumenis, Ltd. · Apr 15, 2003
K103501 — ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES · Alma Lasers, Inc. · Jan 14, 2011
K963339 — COHERENT ULTRAPULSE CO2 SURGICAL LASERS · Coherent Medical Group · Jan 22, 1997
K151655 — CO2RE System · Syneron Medical, Ltd. · Sep 15, 2015
K063001 — SLIM EVOLUTION FAMILY OF CO2 LASERS AND DELIVERY DEVICE ACCESSORIES · Lasering S.R.L. · Mar 7, 2007

Submission Summary (Full Text)

{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.