(86 days)
The OcuLight TX is intended for use in otolaryngological, dermatological and ophthalmic surgical procedures. In otolaryngology it is indicated for stapedectomy, stapedotomy, myringotomy, lysis of adhesions, control of bleeding, removal of acoustic neuromas, and soft tissue adhesion in micro/macro otologic procedures. In dermatology it is indicated for the treatment of vascular and pigmented skin lesions. In ophthalmology it is indicated for retinal photocoagulation, laser trabeculoplasty, iridotomy, and iridoplasty.
The OcuLight TX is a solid state laser that delivers true continuous wave green laser (532 nm) light for otolaryngologic, dermatology, and ophthalmic applications. The integrated system is comprised of the OcuLight TX laser console, various compatible optical fiber delivery devices, and a Footswitch. The laser console contains the laser head, imaging optics, power supplies, control electronics, and firmware. The electronic system is comprised of various sense and control electronics, user controls and displays, and an embedded microprocessor that monitors all system functions. The microprocessor interprets operator commands, formats displays and supervises laser emission. A visible red (630-650 nm) semiconductor diode laser is used for aiming.
The provided text is a 510(k) summary for the IRIDEX OcuLight TX device. It outlines the device's general information, predicate devices, product description, and indications for use. However, it does not contain any information regarding acceptance criteria, study performance data, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices based on similar indications for use, device operation, and technical characteristics. It states: "The OcuLight TX shares the same or similar indications for use, device operation, overall the Oculergit 12x shares the same ies and therefore is substantially equivalent to the predicate devices." and "The review of the indications for use and technical characteristics provided demonstrates that the OcuLight TX is substantially equivalent to the predicate devices."
Therefore, based on the provided text, I cannot answer the requested questions about acceptance criteria and study details.
§ 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.