The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Novus 3000 Laser System And Delivery Devices.
| Device ID | K052526 |
| 510k Number | K052526 |
| Device Name: | NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUMENIS, INC. 2400 CONDENSA ST. Santa Clara, CA 95051 -0901 |
| Contact | Karen L Baker |
| Correspondent | Karen L Baker LUMENIS, INC. 2400 CONDENSA ST. Santa Clara, CA 95051 -0901 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-14 |
| Decision Date | 2005-11-15 |
| Summary: | summary |