# K222395: Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo

- Pathway: 510(k) (Traditional)
- Applicant: Ellex Medical Pty, Ltd.
- Decided: Nov 2, 2022 after 86 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: 2 generations back to K021550 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212630: Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo, Ellex Medical Pty, Ltd. (2021) Summary page 5.

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

Source page: https://510kreport.com/device/K222395
Methodology: https://510kreport.com/methodology