# K130195: Scanning Laserlink

- Pathway: 510(k) (Abbreviated)
- Applicant: Lumenis, Inc.
- Decided: Nov 1, 2013 after 277 days
- Product code: HQF (Laser, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K894841 (1989). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111493: Nidek Multicolor Scan Laser Photocoagulator MC-500 Vixi, Nidek Co., Ltd. (2011) Summary page 1.
- K111108: Pascal Streamline 577 (with Accessories), Topcon Medical Laser Systems, Inc. (2011) Summary page 3.
- K100019: Pascal Streamline Photocoagulator, Optimedica Corporation (2010) Summary page 3.
- K111213: Vision One Laser System, Lumenis, Inc. (2011) Summary page 4.

## Recalls of this device
- Aug 15, 2014 · Class II · Z-2733-2014: Lumenis initiated a field-correction for the Array Laser Link", GA-0006700 (SN XXYYZZ) because the system may project an erroneous pattern display on the retina, which is different than the desir

## Indications for use
The Lumenis® Array Tm LaserLink TM device is a laser system accessory intended for use in the treatment of ocular pathology. "For the posterior segment, the Lumenis® Array"rm LaserL-ink TM device is indicated for use in-retinal photocoagulation and panretinal photocoagulation of vascular and structural abnormalities of the retina and choroid including: o Proliferative and severe and very severe nonproliferative diabetic retinopathy o Macular edema associated with proliferative or nonproliferative diabetic retinopathy o Choroidal neovascularization o Retinal neovascularization associated with retinal occlusive disease (Branch retinal vein occlusion; Central retinal vein occlusion) - o Macular edema associated with Branch retinal vein occlusion o Retinal tears and detachments * And anterior segments as follows: o Iridotomy in closed angle glaucoma o Trabeculoplasty in open angle glaucoma The Lumenis Laser Systems compatible for connection with the Lumenis® Array LaserL-ink TM device are: * Novus Spectra~"' Laser System (K022327)(532nm) " Novus Spectra Dual Port Laser System (K022327)(532nm) * Vision One" ' Laser System (K111213)(532nm, 577nm, 659nm)

Source page: https://510kreport.com/device/K130195
Methodology: https://510kreport.com/methodology