FDA 510(k)

Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo

K-Number: K212630 · 2021-12-16

Decision Date2021-12-16

Product CodeHQF

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo is a medical device manufactured by Ellex Medical Pty, Ltd.. It received FDA 510(k) clearance on 2021-12-16 under approval number K212630. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo?

Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo is a medical device that received FDA 510(k) clearance on 2021-12-16. It is manufactured by Ellex Medical Pty, Ltd.. The 510(k) number is K212630.

When was Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo approved by the FDA?

Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo received FDA 510(k) clearance on 2021-12-16, under approval number K212630.

What company makes Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo?

Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo is manufactured by Ellex Medical Pty, Ltd..

What is the FDA product code for Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo?

The FDA product code for Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo is HQF.

Other Devices by Ellex Medical Pty, Ltd.

K190786Eye Prime K222395Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.