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510(k) Data Aggregation
K Number
K190448Device Name
LightLas Pattern Scanning System - TruScan Pro
Manufacturer
Date Cleared
2019-05-24
(88 days)
Product Code
Regulation Number
886.4390Why did this record match?
Applicant Name (Manufacturer) :
Light-Med(USA), INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
There are four selected wavelengths (532nm, 577mm, 810mm) in TruScan Pro Laser Console integrated with single/multi spots of TruScan module integrated with slitlamp or single spot of LIO or endo ocular probes.
The 532nm and 810nm laser wavelengths are intended to be used for:
- · Pan-retinal photocoagulation for proliferative diabetic retinopathy- with Slitlamp or Endoprobe
- · Laser retinopexy for retinal tear and detachments with Slitlamp or Endoprobe
- · Focal or grid photocoagulation for clinically significant macular edema (CSME)- with Slitlamp
- Focal photocoagulation for choroidal neovascularization (CNV) including but not limited to CNV in the setting of wet age-related macular degeneration (wet AMD)- with Slitlamp
- · Trabeculoplasty for primary open angle glaucoma (POAG)- with Slitlamp
The 577nm laser wavelength is in the treatment of ocular pathology in the posterior segment; Retinal photocoagulation, panretinal photocoagulation, focal photocoagulation and grid photocoagulation for vascular and structure abnormalities of the retina and choroid including:
- · Proliferative and Severe and very severe nonproliferative diabetic retinopathy
- · Clinically Significant Macular edema
- · Choroidal neovascularization
- · Branch and central retinal vein occlusion
- · The treatment of choroidal neovascularization associated with wet age-related macular degeneration
- · Lattice degeneration
- · Retinal tears and detachments
The 670 nm laser wavelength is indicated for retinal and pan-retinal photocoagulation.
Device Description
There are four selected laser wavelengths in TruScan Pro Laser console consists of integrated slitlamp for single and multi-spots laser delivery or optional LIO, Endoocular probes laser delivery units. The 532nm or 577nm laser wavelength is the primary treatment laser or configured with 670nm or 810nm secondary treatment laser to be used. Laser console is developed along with the Electronic Control system, Power Supplies, and PC Interface platform inside, and connect with 15'' LCD touch display and ophthalmic Electrical Table for use.
The TruScan Pro compatible Laser delivery units include:
TruScan module Integrated CSO SL980/SL9800 slitlamp (K992836)
Laser Indirect Ophthalmoscope using a Keeler All pupil II (K854244)
Endophotocoagulation handpieces (compatible with 510(k) cleared ophthalmic endo probes)
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