K081565 is an FDA 510(k) clearance for the INTEGRE PRO, MODEL L2RY. This device is classified as a Laser, Ophthalmic (Class II - Special Controls, product code HQF).
Submitted by Ellex Medical Pty, Ltd. (Adelaide, South Australia, AU). The FDA issued a Cleared decision on July 2, 2008, 28 days after receiving the submission on June 4, 2008.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.
| 510(k) Number | K081565 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2008 |
| Decision Date | July 02, 2008 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQF - Laser, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4390 |