Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K222395 FDA 510(k)
- FDA Product Code
- HQF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.4390 FDA 510(k)
- Regulation Number
- 886.4390 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Tango Neo, Tango Reflex Neo, and Ultra Q Reflex Neo are ophthalmic laser devices designed for retinal and anterior segment procedures. These devices utilize laser technology to treat conditions such as diabetic retinopathy, macular degeneration, and glaucoma, delivering precise energy to targeted ocular tissues for therapeutic or diagnostic purposes.
These devices are supplied as reusable medical equipment, intended for use in clinical settings such as ophthalmology clinics and hospitals. They are classified as Class II devices under FDA regulations and comply with the Medical Device Directive (MDD) and Medical Device Regulation (MDR) in the EU. The Tango Neo, Tango Reflex Neo, and Ultra Q Reflex Neo are authorized through FDA 510(k) clearance and are intended for MRI-unsafe environments due to their electromagnetic properties. Proper storage and maintenance are required to ensure functionality and sterility where applicable.
Frequently asked questions
Are these devices single-use or reusable, and what does that mean for my clinical workflow?
The Tango Neo, Tango Reflex Neo, and Ultra Q Reflex Neo are reusable ophthalmic laser devices, meaning they are designed for repeated use in clinical settings like hospitals and ophthalmology clinics. Since they are reusable, proper cleaning, maintenance, and sterilization protocols must be followed between procedures to ensure patient safety and device functionality. The manufacturer provides guidelines for this process, which should be strictly adhered to in your facility.
What types of retinal and anterior segment conditions can these devices treat, and how do they work?
These devices are ophthalmic laser systems used for treating conditions like diabetic retinopathy, macular degeneration, and glaucoma. They deliver precise laser energy to targeted ocular tissues, either for therapeutic (e.g., reducing retinal swelling or sealing leaking blood vessels) or diagnostic purposes. The specific laser parameters (wavelength, power, duration) are adjusted based on the clinical indication and procedure, ensuring controlled treatment of the affected area.
Can these devices be used in an MRI environment, and why?
No, these devices are not MRI-safe and should not be used in an MRI environment. The devices contain electromagnetic components that could interfere with MRI systems or be damaged by the strong magnetic fields used in MRI scans. Always ensure the device is placed outside the MRI scan room and follow facility protocols for electromagnetic interference risks.
What regulatory pathways have these devices undergone, and how does that affect their use in my country?
The Tango Neo, Tango Reflex Neo, and Ultra Q Reflex Neo have undergone FDA 510(k) clearance in the U.S. and comply with the EU Medical Device Directive (MDD) and Medical Device Regulation (MDR). This means they meet the necessary safety and performance standards for their intended use in ophthalmology. However, regulatory requirements may vary by country, so verify local compliance and approvals before use. The devices are classified as Class II under FDA regulations, indicating a moderate risk level requiring specific documentation and adherence to guidelines.
How should these devices be stored to maintain their functionality and safety?
These reusable devices require proper storage and maintenance to ensure functionality and hygiene. They should be stored in a clean, dry environment, away from direct sunlight, extreme temperatures, and electromagnetic interference. Since they are not MRI-safe, they must be kept outside MRI zones. Additionally, follow the manufacturer’s instructions for regular servicing, calibration, and cleaning to prevent damage and ensure reliable performance during procedures.
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
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K222395 | Class II | Active |
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Manufacturer
- Manufacturer
- Ellex Medical Pty Ltd
- FDA Applicant
- Ellex Medical Pty, Ltd.
Sources (2)
- FDA 510(k) K222395 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026