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K Number
K091981
Device Name
LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER
Manufacturer
LIGHTMED CORP.
Date Cleared
2009-09-28

(89 days)

Product Code
HQF,HOF
Regulation Number
886.4390
Type
Traditional
Panel
OP
Reference & Predicate Devices
K071687,K063297,K022181
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The LightLas 577 Medical Optical Pumped Semiconductor Laser is intended for use in ophthalmic surgical procedures. A complete list is contained in the Indications for Use Statement.

Ophthalmology:

  • . Retinal Photocoagulation
  • Pan Retinal Photocoagulation .
  • Endophotocoagulation ●
  • Macular Photocoagulation
  • Laser Trabeculoplasty (to treat Open Angle Glaucoma)
Device Description

The LightLas 577 Laser beam has a wavelength of 577mm, which is in the visible spectrum and is a Yellow light. A red aiming beam is used to position the treatment Yellow beam prior to delivery.

The LightLas 577 is a solid state, Optical Pumped Semiconductor surgical laser. It's an instrument used in the photothermolysis (photocoagulation) of soft tissue at en emission wavelength of 577nm.

LightLas LaserLink : Laser delivery adapter that may be coupled to each of the above Selecta models and connected to a currently cleared LightLas 577 retinal photocoagulator to allow use of the slit lamp to deliver 577 nm continuous wave laser energy for retinal photocoagulation.

Compatible delivery devices include: slit lamps, slit lamp adapters/ attachments, laser indirect ophthalmoscopes(LIO) and endoprobe.

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to complete the request regarding acceptance criteria and study data for the LightLas 577 Medical Optical Pumped Semiconductor Laser.

The text is a 510(k) summary and FDA clearance letter, which primarily focuses on establishing substantial equivalence to predicate devices and regulatory compliance.

Here's what is missing from the provided text that would be needed to answer your questions:

  • Specific Acceptance Criteria: The document states "The appropriate testing including safety, performance and functional testing to determine The appropriate testing methoding Laser System." but it does not list what those acceptance criteria were for performance metrics.
  • Reported Device Performance: While it mentions testing was done, it does not provide any quantitative results or data on the device's performance against any specific metrics.
  • Details of the Study: There is no description of any specific study (clinical, standalone, or MRMC) that was conducted to prove the device meets acceptance criteria.
    • No information on sample sizes (test set, training set).
    • No data provenance (country, retrospective/prospective).
    • No number of experts, their qualifications, or adjudication methods for ground truth.
    • No mention of MRMC comparative effectiveness or effect sizes.
    • No indication of a standalone performance study.
    • No type of ground truth used (pathology, outcomes, etc.) for any potential study.
    • No information on how ground truth was established for a training set.

The document primarily focuses on:

  • Device description and intended use.
  • Technological characteristics and comparison to predicate devices for substantial equivalence.
  • Regulatory classifications and standards met.
  • FDA's clearance decision.

Therefore, I cannot generate the requested table or answer the specific questions about the study design and results from the provided input.

§ 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.