K212630 is an FDA 510(k) clearance for the Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo. This device is classified as a Laser, Ophthalmic (Class II - Special Controls, product code HQF).
Submitted by Ellex Medical Pty, Ltd. (Adelaide, AU). The FDA issued a Cleared decision on December 16, 2021, 119 days after receiving the submission on August 19, 2021.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.
| 510(k) Number | K212630 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 2021 |
| Decision Date | December 16, 2021 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQF - Laser, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4390 |