The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Coherent Laserlink Z-1000 Slit Lamp Laser Delivery Adapter.
| Device ID | K000498 |
| 510k Number | K000498 |
| Device Name: | COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUMENIS, INC. 2400 CONDENSA ST. Santa Clara, CA 95051 -0901 |
| Contact | Edward C Yu |
| Correspondent | Edward C Yu LUMENIS, INC. 2400 CONDENSA ST. Santa Clara, CA 95051 -0901 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-15 |
| Decision Date | 2000-03-13 |