(89 days)
The Laserscope Erbium:YAG Laser System and Accessories are indicated for use in procedures involving cutting (incision/excision), vaporizing and coagulating soft tissue. All soft tissue is included such as skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Clinical Applications: Dermatology/Plastic Surgery General Surgery (Soft Tissue) Genitourinary Gynecology ENT Soft Tissue Procedures Oral and Maxillofacial Surgery Ophthalmology Podiatry
The Laserscope Erbium:YAG Laser System and Accessories consists of a moveable console containing power supplies, aiming and treatment lasers on a solid optical deck and a cooling mechanism to dissibate the heat generated by the system. A softouch keypad control panel with LCD displays enables the user to control the laser system operating parameters. The aiming beam is coincident with the Erbium: YAG beam and passes through an articulating arm. The aiming beam emerges at the distal end of a handpiece. Focusing handpiece adapters, which attach to the handpiece, are available in spot sizes of 1 - 5 mm.
This is a 510(k) premarket notification for a laser system, not a device that relies on algorithms, AI, or specific performance metrics related to diagnostic accuracy or clinical outcomes that would typically be evaluated in a study with acceptance criteria like sensitivity, specificity, or AUC.
Therefore, the provided text does not contain the information requested for a table of acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
The document focuses on:
- Regulatory classification and standards: Conformance with federal regulations and performance standards for medical laser systems (21 CFR 1040.10 and 1040.11).
- Intended Use: Cutting, vaporizing, and coagulating soft tissue in various clinical applications.
- Substantial Equivalence: Comparison to a predicate device (SEO Medical Trilase 2490) based on indications for use, materials, method of operation, and physical construction.
There is no mention of a study involving "acceptance criteria" in the sense of a performance study for AI/algorithmic medical devices. The safety and effectiveness are "reasonably assured" based on its substantial equivalence to an already cleared device and adherence to general laser safety standards.
§ 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.