The following data is part of a premarket notification filed by Ellex Medical Pty. Ltd. with the FDA for Laserex Lp1532 Photocoagulator.
| Device ID | K972514 |
| 510k Number | K972514 |
| Device Name: | LASEREX LP1532 PHOTOCOAGULATOR |
| Classification | Laser, Ophthalmic |
| Applicant | Ellex Medical Pty. Ltd. 258 HALIFAX ST. Adelaide, S.a., AU 5000 |
| Contact | Keith R Degenhardt |
| Correspondent | Keith R Degenhardt Ellex Medical Pty. Ltd. 258 HALIFAX ST. Adelaide, S.a., 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 | 1997-07-07 |
| Decision Date | 1997-10-03 |
| Summary: | summary |