(79 days)
Intended Use:The V-Raser is intended for Incision, excision, ablation, vaporization and coagulation of soft tissue.
Specific Indications: Treatment of vascular lesions.
The V-RASER Diode System is a modified Diodent Micro 980. It will use similar specifications (laser medium, excitation method, fiber optic beam delivery, electrical requirements, physical specifications) as the Diodent Micro 980. The laser source of this device is a solid-state Gallium Aluminum Arsenide (GaAlAs) semiconductor diode. It produces invisible laser energy at the 980-nanometer wavelength. The delivery system consists of removable flexible HCS (hard clad silica) optical treatment fiber assembly connected to a lightweight, hand piece that has two different size end pieces (tips) to adjust the laser beam to specific spot sizes. Activation occurs when the operator enables the laser by a key switch, enters the Ready Mode and presses the footswitch. Releasing the footswitch suspends laser treatment. A color LCD and touch-screen display panel allows the operator to adjust or set the laser output level. The laser operates in a pulsed mode and will have a removable stainless steel end piece for establishing the proper focal length for the treatment. The hand piece will be manually attached (i.e., screwed on) to a connector to the fiber assembly. The spot size will be selected on the control panel and the software will calculate the treatment fluence accordingly.
The provided 510(k) summary for the V-RASER Diode Laser System does not contain information about acceptance criteria or a study proving the device meets them.
Instead, it's a premarket notification for a medical device seeking substantial equivalence to a predicate device. The document explicitly states:
- Nonclinical Performance Data: None
- Clinical Performance Data: None
Therefore, I cannot provide the requested information. This device was cleared based on its similarity to existing, legally marketed devices, rather than through a study demonstrating its performance against specific acceptance criteria.
The information regarding the training set, test set, ground truth, expert qualifications, and adjudication methods is typically found in clinical or performance studies, which were not submitted for this 510(k) application.
§ 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.