# K190448: LightLas Pattern Scanning System - TruScan Pro

- Pathway: 510(k) (Traditional)
- Applicant: Light-Med (Usa), Inc.
- Decided: May 24, 2019 after 88 days
- Product code: HQF (Laser, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K894841 (1989). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142172: Lightmed Truscan 577, Lightmed Corp. (2015) Summary page 4.

## Indications for use
There are four selected wavelengths (532nm, 577nm, 670nm, 810nm) 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.

Source page: https://510kreport.com/device/K190448
Methodology: https://510kreport.com/methodology