# K021550: Lumenis Selecta Duet

- Pathway: 510(k) (Traditional)
- Applicant: Ellex Medical Pty, Ltd.
- Decided: Aug 9, 2002 after 88 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 6 cite 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K081704: Selecta Family of Ophithalmic Laser Systems (2008), 9 descendants of its own
- K130933: Solutis (2013), 4 descendants of its own
- K212630: Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo (2021), 3 descendants of its own
- K140336: Optimus Fusion: SLT, Yag and Yag/SLT (2014), 3 descendants of its own
- K220877: Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems (2022), 2 descendants of its own

## Indications for use
POSTERIOR CAPSULOTOMY TRIDOTOMY / IRIDECTOMY POSTERIOR MEMBRANECTOMY SELECTIVE LASER TRABELULOPLASTY (SLT)

Source page: https://510kreport.com/device/K021550
Methodology: https://510kreport.com/methodology