# K152688: LightLas Multi-Wavelength Medical Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Lightmed Corporation
- Decided: Jun 15, 2016 after 271 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: 11 generations back to K910422 (1992). 145 ancestors in all.
No later device cites it as a predicate yet.
0 of 146 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081946: Supra Twin Ophthalmic Laser Photocoagulator, Quantel Medical (2009) Summary page 4.
- K103547: Lightlas Multi-Wavelength Medical Laser System, Lightmed Corp. (2011) Summary page 4.

## Indications for 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

Source page: https://510kreport.com/device/K152688
Methodology: https://510kreport.com/methodology