The following data is part of a premarket notification filed by Ellex Medical Pty. Ltd. with the FDA for Laserex Nd:yag Ophthalmic Laser (lq2106), Alcon Nd:yag Ophthalmic Laser (3000le), Laserex Nd:yag Ophthalmic Laser, Model.
| Device ID | K992824 |
| 510k Number | K992824 |
| Device Name: | LASEREX ND:YAG OPHTHALMIC LASER (LQ2106), ALCON ND:YAG OPHTHALMIC LASER (3000LE), LASEREX ND:YAG OPHTHALMIC LASER, MODEL |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Ellex Medical Pty. Ltd. 258 HALIFAX ST. Adelaide, S.a., AU 5000 |
| Contact | Keith Degenhardt |
| Correspondent | Keith Degenhardt Ellex Medical Pty. Ltd. 258 HALIFAX ST. Adelaide, S.a., 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 | 1999-08-23 |
| Decision Date | 1999-11-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09342395000427 | K992824 | 000 |