The following data is part of a premarket notification filed by Ellex Medical Pty. Ltd. with the FDA for Laserex Duo Family Of Dual Wavelength Ophthalmic Lasers Including Models Integre Duo Lp1rg-s, Lp1rg-d.
| Device ID | K052777 |
| 510k Number | K052777 |
| Device Name: | LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D |
| Classification | Powered Laser Surgical Instrument |
| 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 | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-03 |
| Decision Date | 2006-03-16 |