(90 days)
The Ceralas H Laser System is a surgical instrument indicated to treat leg veins in dermatology and plastic surgery procedures. Specific indications for the Ceralas H Laser System include the treatment of leg veins.
The Ceralas H 808nm Diode Laser System is indicated to treat leg veins in dermatology and plastic surgery procedures.
The Ceralas H Laser System is a complete, self-contained compact surgical laser that utilizes gallium alumnum arsenide (GaAlAs) semiconductor diodes to generate near-infrared laser radiation. The laser system consists of a console, footswitch, and handpiece which are connected to the device's console. The diode laser is enclosed in a rugged, factory aligned, environmentally protective module. The handpiece is placed against the patient's skin and a pulse of light is delivered to the skin surface when the footswitch and handpiece trigger are depressed.
The wavelength for the Ceralas H Laser System is 808 ± 20nm. The laser delivers pulsed light with a selectable pulse duration of 5-30 millsseconds and a fluence of 10-40J/cm2. The corresponding pulse energy delivered through the 9x9mm handpiece is 8-32 Joules. The laser pulses are generated at a maximum pulse repetition frequency of up to 1 Hz. Additionally, the software and software development activities are in accordance with FDA's guidance document. "Reviewer Guidance For Computer Controlled Medical Devices Undergoing 510(k) Review."
The provided text does NOT describe acceptance criteria or a study proving the device meets acceptance criteria.
The document is a 510(k) summary for the Ceralas Diode Laser System, which focuses on establishing substantial equivalence to a predicate device (StarLight™ Pulsed Diode Array Laser System) for regulatory clearance.
Specifically, the "Performance Data" section states: "None required." This indicates that for this particular 510(k) submission, the FDA did not require the applicant to submit performance data from a clinical or human-based study to demonstrate the device's efficacy or safety against specific acceptance criteria. The clearance was based on technological characteristics and a declaration of substantial equivalence to a legally marketed predicate device.
Therefore, I cannot provide the requested information because it is not present in the given text.
§ 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.