# K220877: Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis Be, Inc.
- Decided: Jul 15, 2022 after 112 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.
2 later devices descend from it; 1 cites it directly.
0 of 17 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 4.

## Most influential descendants
- K230722: Eagle device (2023), 1 descendant of its own
- K252979: Voyager DSLT (430840610) (2026), 0 descendants of its own

## Indications for use
* Selecta Duet LED or Digital Duet: Photodisruption of ocular tissue using light energy emitted by a Nd:YAG laser, including discission of the posterior capsule of the eye (posterior capsulotomy), iridotomy/ iridectomy, and selective laser trabeculoplasty. * Selecta LED Trio or Digital Trio: Photodisruption of ocular tissue using light energy emitted by a Nd:YAG laser, including discission of the posterior capsule of the eye (posterior capsulotomy), iridotomy/ iridectomy, selective laser trabeculoplasty, and retinal photocoagulation.

Source page: https://510kreport.com/device/K220877
Methodology: https://510kreport.com/methodology