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510(k) Data Aggregation
K Number
K152688Device Name
LightLas Multi-Wavelength Medical Laser System
Manufacturer
Date Cleared
2016-06-15
(271 days)
Product Code
Regulation Number
886.4390Why did this record match?
Applicant Name (Manufacturer) :
LIGHTMED CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
LightLas 532/810 Multi-Wavelength Medical Laser System is 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
Device Description
LightLas 532/810 Multi-Wavelength Medical Laser System can emit 532 nm wavelength laser beam and 810 nm wavelength laser beam. The 532 nm wavelength source can be delivered through both output ports (Ports 1 and 2) of the laser console, while the 810 nm wavelength source is delivered through Port 1 only. Users may choose either wavelength from a LCD touch screen, and only one output port and one wavelength may be selected for use at a time. Laser wavelength selection of the system is indicated on the panel and controlled by system software.
LightLas 532/810 Multi-Wavelength Medical Laser System is intended for use by ophthalmologists for treatment of ocular pathology, and the system consists of the following functional components:
- LCD touch panel ●
- Laser Console
- Ophthalmic Instrument table ●
- CSO Slitlamp SL980 (K992836) ●
- Endolaser probe (K133019)
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