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

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K212630Ref LT5106-T

by Ellex Medical Pty Ltd

Identity

Trade Name
Tango EUDAMEDFDA UDI
Generic Name
Ophthalmic solid-state laser system FDA UDI
Device Name
Tango EUDAMED
Model / Reference
LT5106-T EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
09342395000113 EUDAMEDFDA UDI
Basic UDI-DI
B-09342395000113 EUDAMED
9342395YAGSLT6M EUDAMED
510(k) Number
K212630 FDA 510(k)FDA UDI
FDA Product Code
HQF FDA 510(k)FDA UDI
EMDN Code
Z12011017 NEODYMIUM SURGICAL LASER EUDAMED
GMDN Term
Ophthalmic solid-state laser system FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 886.4390 FDA 510(k)
Regulation Number
886.4390 FDA 510(k)FDA UDI
Market of Registration
Poland EUDAMED
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

The Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, and Solo are ophthalmic laser devices used for various eye treatments. These devices are designed to provide precise laser treatment for ophthalmic conditions.

The devices are supplied by Ellex Medical Pty Ltd and are authorized under FDA 510K, MDD, and MDR regulations. They are manufactured in Adelaide, Australia, and are intended for use in ophthalmic settings with appropriate regulatory approvals.

Frequently asked questions

What are the Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, and Solo devices used for?

These are ophthalmic laser devices designed to provide precise laser treatment for various eye conditions in ophthalmic settings.

How are these devices supplied?

The devices are supplied by Ellex Medical Pty Ltd and are manufactured in Adelaide, Australia.

What regulatory approvals do these devices have?

The devices are authorized under FDA 510K, MDD, and MDR regulations, with a product code of HQF and device class of 2.

Are there different models available in this device line?

Yes, the device line includes Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, and Solo models, all designed for ophthalmic laser treatments.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ellex Medical Pty Ltd
FDA Applicant
Ellex Medical Pty, Ltd.

Sources (4)

  • FDA 510(k) K212630 24 fields · synced Sep 18, 2026
  • FDA UDI bbf14a97-d659-4c4f-aff1-e061f86fbc43 34 fields · synced May 30, 2026
  • EUDAMED 3ad04a72-6230-4852-bad3-97454b1ae4fb 61 fields · synced Jul 10, 2026
  • EUDAMED b6895c20-2b92-45c7-8b3c-b44d1b2a2e88 61 fields · synced Jul 17, 2026