(164 days)
The Laserex Duo family of dual wavelength ophthalmic lasers are intended for use in the treatment of ocular pathology.
The Laserex Duo is indicated for use in photocoagulation of both anterior and posterior segments of the eye including:
- Retinal photocoagulation and pan retinal photocoagulation of vascular and . structural abnormalities of the retina and choroid including:
- proliferative and nonproliferative diabetic retinopathy; -
- choroidal neovascularization; -
- branch retinal vein occlusion; -
- age-related macular degeneration;
- retinal tears and detachments; -
- retinopathy of prematurity; -
- Iridotomy, iridectomy, suturelysis and trabeculoplasty in angle closure glaucoma . and open angle glaucoma
Not Found
The provided text is a 510(k) summary for the Laserex Duo family of ophthalmic lasers. It describes the device, its intended use, and the FDA's determination of substantial equivalence to a predicate device.
*However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the detailed study parameters you've requested.
This type of FDA clearance letter (510(k) summary) primarily focuses on establishing substantial equivalence to a legally marketed predicate device, not on presenting detailed performance data from new clinical studies against specific acceptance criteria.
Therefore, I cannot provide the requested information based on the given text.
§ 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.