# K130933: Solutis

- Pathway: 510(k) (Traditional)
- Applicant: Quantel Medical
- Decided: Aug 2, 2013 after 120 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: 4 generations back to K894841 (1989). 14 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021550: Lumenis Selecta Duet, Ellex Medical Pty, Ltd. (2002) Summary page 2.
- K081704: Selecta Family of Ophithalmic Laser Systems, Lumenis, Inc. (2008) Summary page 2.

## Most influential descendants
- K140336: Optimus Fusion: SLT, Yag and Yag/SLT (2014), 3 descendants of its own
- 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
Selective Laser Trabeculoplasty (SLT)

Source page: https://510kreport.com/device/K130933
Methodology: https://510kreport.com/methodology