The following data is part of a premarket notification filed by Ellex Medical Pty. Ltd. with the FDA for Integre Pro, Model L2ry.
| Device ID | K081565 |
| 510k Number | K081565 |
| Device Name: | INTEGRE PRO, MODEL L2RY |
| Classification | Laser, Ophthalmic |
| Applicant | Ellex Medical Pty. Ltd. 82 GILBERT ST. Adelaide, South Australia, AU 5000 |
| Contact | Kevin Howard |
| Correspondent | Kevin Howard Ellex Medical Pty. Ltd. 82 GILBERT ST. Adelaide, South Australia, AU 5000 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-04 |
| Decision Date | 2008-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09342395001172 | K081565 | 000 |
| 09342395001165 | K081565 | 000 |
| 09342395000861 | K081565 | 000 |
| 09342395000878 | K081565 | 000 |
| 09342395000236 | K081565 | 000 |
| 09342395000120 | K081565 | 000 |
| 09342395000106 | K081565 | 000 |
| 09342395000090 | K081565 | 000 |