The following data is part of a premarket notification filed by Ellex Medical Pty. Ltd. with the FDA for Integre, Model Lp581.
| Device ID | K080423 |
| 510k Number | K080423 |
| Device Name: | INTEGRE, MODEL LP581 |
| 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 | 2008-02-15 |
| Decision Date | 2008-03-11 |
| Summary: | summary |