# K140336: Optimus Fusion: SLT, Yag and Yag/SLT

- Pathway: 510(k) (Traditional)
- Applicant: Quantel Medical
- Decided: Jun 25, 2014 after 135 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: 5 generations back to K894841 (1989). 16 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081704: Selecta Family of Ophithalmic Laser Systems, Lumenis, Inc. (2008) Summary page 2.
- K042139: Visulas Yag Iii, Carl Zeiss Meditec, AG (2004) Summary page 2.
- K130933: Solutis, Quantel Medical (2013) Summary page 2.

## Most influential descendants
- K192045: Ophthalmic Yag Laser System YC-200 (2019), 1 descendant of its own
- K220430: Capsulo (2022), 0 descendants of its own
- K203130: Ophthalmic Yag Laser System YC-200 (2020), 0 descendants of its own

## Indications for use
* OPTIMIS FUSION YAG: photodisruption of ocular tissue using light energy emitted by a Nd: YAG Laser, including discission of posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy. * OPTIMIS FUSION SLT: Selective laser Trabeculoplasty * OPTIMIS FUSION YAG/SLT: photodisruption of ocular tissue using light energy emitted by a Nd: YAG Laser, including discission of posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy; and Selective laser Trabeculoplasty

Source page: https://510kreport.com/device/K140336
Methodology: https://510kreport.com/methodology