The following data is part of a premarket notification filed by Ellex Medical Pty Ltd with the FDA for Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo.
| Device ID | K222395 |
| 510k Number | K222395 |
| Device Name: | Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo |
| Classification | Laser, Ophthalmic |
| Applicant | Ellex Medical Pty Ltd 3-4 Second Avenue Mawson Lakes Adelaide, AU |
| Contact | Rashmi Pillay |
| Correspondent | Maureen O`Connell O`Connell Regulatory Consultants, Inc. 44 Oak Street Stoneham, MA 02180 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-08 |
| Decision Date | 2022-11-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09342395002223 | K222395 | 000 |
| 09342395002216 | K222395 | 000 |
| 09342395002209 | K222395 | 000 |