(34 days)
The Revolix 120 laser systems and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery and Arthroscopy
The RevoLix 120 laser system is diode pump solid state surgical laser system operating at a wavelength of 2.01 micron. The purpose of the laser is the ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery, laparoscopic and surgical applications in aqueous media. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a handpiece or endoscopic/laparoscopic surgical instrument. It consists of: Laser Console with Internal Computer Control Panel and Display A fiber optic delivery system Footswitch
The provided 510(k) summary for the RevoLix 120 Laser System does not contain acceptance criteria or study data demonstrating the device meets such criteria.
The document is a premarket notification for substantial equivalence, which aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This type of submission typically relies on a comparison of design, materials, and intended use to predicate devices, rather than new clinical trials or detailed performance acceptance criteria.
Therefore, I cannot provide the requested table and information as it is not present in the given text. The document focuses on:
- Device identification and classification.
- Identification of predicate devices: Lumenis/Coherent Medical - VersaPulse Ho:YAG 100 watt, Trimedyne Omnipulse Max 80 watt, RevoLix 90 watt.
- Product description: Diode pump solid state surgical laser system operating at 2.01 micron for ablation, coagulation, dissection, and resection of soft tissue.
- Indications for Use: Extensive list across various medical specialties (Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery, Arthroscopy).
- Rationale for Substantial Equivalence: Stating the RevoLix 120 shares "the same intended use, indications for use, similar design features and functional features" with the Lumenis VersaPulse Laser.
- Conclusion: The device was found substantially equivalent to predicate surgical laser systems.
In summary, none of the requested information regarding acceptance criteria, performance data, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies is available in this 510(k) submission. These details would typically be found in performance data sections of a 510(k) submission, clinical trial reports, or other regulatory filings, which are not included here.
§ 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.