The following data is part of a premarket notification filed by Ellex Medical Pty Ltd with the FDA for Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo.
| Device ID | K212630 |
| 510k Number | K212630 |
| Device Name: | Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo |
| 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 | 2021-08-19 |
| Decision Date | 2021-12-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09342395000427 | K212630 | 000 |
| 09342395000137 | K212630 | 000 |
| 09342395000113 | K212630 | 000 |
| 09342395000069 | K212630 | 000 |
| 09342395000038 | K212630 | 000 |