(183 days)
The Uni-Laser™ 430 is intended for use in hair removal (destruction of hair follicles) in skin types I-IV, and for soft tissue applications, such as coagulation of soft tissue, e.g., vascular lesions (visible blood vessels)
In contact mode the Uni-Laser 430 can be used for vaporization, ablation, incision, and excision of soft tissue.
MedArt Corporation Uni-Laser™ 430
This document is a 510(k) clearance letter from the FDA for the MedArt Corporation Uni-Laser™ 430. It focuses on the regulatory approval of the device and its intended uses.
Unfortunately, this document does not contain the specific information required to answer your questions about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.
The provided text only states that the FDA has reviewed the 510(k) notification and determined the device is "substantially equivalent" to legally marketed predicate devices for its stated indications for use: hair removal in skin types I-IV, and soft tissue applications like coagulation of vascular lesions, and in contact mode for vaporization, ablation, incision, and excision of soft tissue.
To answer your questions, I would need a different type of document, such as:
- A clinical study report for the MedArt Corporation Uni-Laser™ 430.
- A detailed technical data submission to the FDA by MedArt Corporation.
- A performance testing report for the device.
Without such documentation, I cannot provide the requested information.
§ 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.