The following data is part of a premarket notification filed by Ellex Medical Pty. Ltd. with the FDA for Laserex, Model Lp4532.
| Device ID | K041598 |
| 510k Number | K041598 |
| Device Name: | LASEREX, MODEL LP4532 |
| Classification | Laser, Ophthalmic |
| Applicant | Ellex Medical Pty. Ltd. 74 TO 86 GILBERT ST. Adelaide, South Australia, AU 5000 |
| Contact | Kevin Howard |
| Correspondent | Kevin Howard Ellex Medical Pty. Ltd. 74 TO 86 GILBERT ST. Adelaide, South Australia, AU 5000 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-14 |
| Decision Date | 2004-10-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09342395000687 | K041598 | 000 |
| 09342395000199 | K041598 | 000 |
| 09342395000670 | K041598 | 000 |
| 09342395000694 | K041598 | 000 |
| 09342395000700 | K041598 | 000 |
| 09342395000786 | K041598 | 000 |
| 09342395000793 | K041598 | 000 |
| 09342395000809 | K041598 | 000 |
| 09342395000885 | K041598 | 000 |
| 09342395001141 | K041598 | 000 |
| 09342395000175 | K041598 | 000 |