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 |