# K212630: Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo

- Pathway: 510(k) (Traditional)
- Applicant: Ellex Medical Pty, Ltd.
- Decided: Dec 16, 2021 after 119 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: 1 generation back to K021550 (2002). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 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 5.

## Most influential descendants
- K230350: VISULAS yag (2023), 1 descendant of its own
- K233911: VISULAS combi (2024), 0 descendants of its own
- K222395: Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo (2022), 0 descendants of its own

## Indications for use
In the YAG mode (Tango, Ultra Q, Ultra Q Reflex, Tango Reflex): -Iridotomy and iridectomy. -Posterior capsulotomy. -Posterior membranectomy. In the SLT mode (Tango, Solo, Tango Reflex): -Selective Laser Trabeculoplasty (SLT)

Source page: https://510kreport.com/device/K212630
Methodology: https://510kreport.com/methodology