(119 days)
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Not Found
No
The provided text describes a CO2 laser system for surgical soft tissue removal and does not mention any AI or ML capabilities.
Yes
The device is intended for the surgical removal and treatment of soft tissue in various medical applications, which directly aligns with the definition of a therapeutic device.
No
Explanation: The CyberLase CO2 Laser System is intended for the "surgical removal" of soft tissue. Its function is to perform therapeutic procedures (excision, incision, cutting, ablation, coagulation, hemostasis, vaporization), not to diagnose conditions.
No
The device is described as a "CO2 Laser System" intended for surgical removal of soft tissue, which inherently involves hardware (the laser system itself). The description of its function (excision, incision, cutting, etc.) further confirms it is a physical device, not software only.
Based on the provided information, the CyberLase CO2 Laser System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for the direct removal of soft tissue in various surgical applications. This is an in vivo procedure (performed on a living organism), not an in vitro procedure (performed outside of a living organism, typically on biological samples).
- Device Description: While the description is "Not Found," the intended use is the primary indicator of whether a device is an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue samples), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The CyberLase CO2 Laser System is a surgical tool used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
The CyberLase CO2 Laser Systems are intended for the surgical removal (i.e., excision, incision, cutting, ablation, coaqulation, homeostasis or vaporization) of soft tissue in all surgical applications with the use of wavelength of 10.6um. 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.
Product codes
79GEX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Head and Neck(ENT), Neurosurgery, General / Plastic Surgery, Dermatology, Oncology, Obstetrics/Gynecology, Orthopedics, Thoracoscopic
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
K9643)3
SUMMARY OF SAFETY AND EFFECTIVENESS
NIDEK CyberLase CO2 LASER SYSTEMS
FEB 2 8 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, coaqulation, homeostasis or vaporization) of soft tissue in all surgical applications with the use of wavelength of 10.6um. 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.