(90 days)
The LightLas 810 Infrared Laser Photocoagulator is indicated for all retinal photocoagulation procedures, such as limited and pan-retinal, transpupillary laser photocoagulation, endophotocoagulation and transscleral photocoagulation, and glaucoma procedures, such as laser trabeculoplasty and iridotomy. The LightLas 810 is used in combination with various delivery systems, such as slitlamps, binocular indirect ophthalmoscopes, endoprobes and transscleral probes.
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This document is a 510(k) clearance letter for the LightLas 810 Infrared Laser Photocoagulator. It states that the device is substantially equivalent to legally marketed predicate devices.
This document does not contain the detailed information necessary to answer your questions regarding acceptance criteria and a study proving the device meets those criteria.
The provided text is a regulatory clearance document from the FDA, which confirms that a medical device (LightLas 810 Infrared Laser Photocoagulator) has been determined to be substantially equivalent to an already legally marketed device (a predicate device). This process is based on comparing the new device's features, indications for use, and technological characteristics to the predicate.
Such a document typically doesn't include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes for test sets, data provenance, or ground truth establishment for a specific study proving performance.
- Information on expert adjudication, MRMC studies, or standalone algorithm performance.
- Training set details or how their ground truth was established.
These kinds of details are usually found in the technical documentation submitted by the manufacturer to the FDA (e.g., in engineering reports, clinical trial summaries, or validation studies), not in the 510(k) clearance letter itself. The clearance letter is the FDA's decision based on its review of that documentation.
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.