(279 days)
The A.R.C. Laser Fox Laser System is indicated for retinal and pan retinal photocoagulation, endophotocoagulation and transcleral cyclophotocoagulation for the treatment of: Diabetic Retinopathy Retinal tears and detachment Age related macular degeneration Retinopathy of prematurity Primary open angle glaucoma Refractory glaucoma
Not Found
The provided text is an FDA 510(k) clearance letter for the A.R.C. Laser Fox Laser System and Accessories. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the detailed study parameters requested in your prompt.
The letter primarily focuses on:
- Confirming the device's substantial equivalence to a predicate.
- Listing the regulation number, regulation name, and product code.
- Indicating the general controls provisions of the Act that apply.
- Providing contact information for device-related inquiries.
- Listing the "Indications For Use" for the device, which describes the medical conditions it is intended to treat.
Therefore, I cannot fulfill your request using the provided text. To answer your questions, I would need a clinical study report, a summary of safety and effectiveness data, or a detailed technical submission for the device that outlines its performance evaluation.
§ 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.