(76 days)
The Uni-laser 425P Diode Laser System and accessories are indicated for incision/excision, ablation, and coagulation (homeostasis) of soft tissue which may be encountered in surgical procedures include skin, subcutaneous tissue, striated and smooth muscle, mucus membrane, lymph vessels and nodes, organs and glands and specifically for the following indications. Specific surgical specialties include:
Dermatology and Plastic Surgery for
Photocoagulation of dermatological vascular lesions Photothermolysis of blood vessels (treatment of facial and leg veins) Removal of pigmented lesions
Dentistry (soft tissue only), including sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), and oral surgery; Ear Nose & Throat; Otorhinolaryngology; Neurosurgery (coagulation only); Ophthalmology/Oculoplastic; Pulmonary/Thoracic Surgery;
Gastroenterology; Urology; Gynecology; Orthopedics; Podiatry; and General Surgery.
Uni-Laser 425P™ Diode Laser System and Accessories
This document is a marketing clearance letter from the FDA for the Uni-Laser 425P™ Diode Laser System and Accessories (K991659). It primarily states that the device is substantially equivalent to legally marketed predicate devices.
Crucially, this document does not contain information about:
- Acceptance criteria or reported device performance.
- Any specific study design, sample sizes, data provenance, expert qualifications, or ground truth establishment.
- Comparative effectiveness studies (MRMC) or standalone algorithm performance.
Therefore, I cannot provide the requested table or detailed study information based on the provided text. The document confirms the device's regulatory clearance but does not delve into the technical details of its performance testing.
§ 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.