# K103547: Lightlas Multi-Wavelength Medical Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Lightmed Corp.
- Decided: Nov 3, 2011 after 336 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: 10 generations back to K910422 (1992). 133 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052777: Laserex Duo Family of Dual Wavelength Ophthalmic Lasers Including Models Integre Duo LP1RG-S, LP1RG-D, Ellex Medical Pty, Ltd. (2006) Summary page 1.
- K022181: Novus Varia Ophthalmic Laser and Delivery Devices with Accessories, Lumenis, Inc. (2002) Summary page 1.
- K042785: Multi Color Laser Photocoagulator, Model MC-300, Nidek, Inc. (2004) Summary page 2.
- K091534: Lightlas Model 532, Lightmed Corp. (2009) Summary page 2.

## Most influential descendants
- K152688: LightLas Multi-Wavelength Medical Laser System (2016), 0 descendants of its own
- K124043: Lightlas Family of Multi-Wavelength Medical Laser System (2013), 0 descendants of its own

## Indications for use
Ophthalmology: 532nim Laser * Retinal Photocoagulation * Pan Retinal Photocoagulation * Endophotocoagulation * Macular photocoagulation to treat leaking vessels * Laser Trabeculoplasty 670nm Laser * Retinal/Pan Retinal Photocoagulation

Source page: https://510kreport.com/device/K103547
Methodology: https://510kreport.com/methodology