The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Novus Verdi Delivery Systems.
| Device ID | K991258 |
| 510k Number | K991258 |
| Device Name: | NOVUS VERDI DELIVERY SYSTEMS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUMENIS, INC. 2400 CONDENSA ST. Santa Clara, CA 95051 -0901 |
| Contact | Kathy A Maynor |
| Correspondent | Kathy A Maynor 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 | 1999-04-13 |
| Decision Date | 1999-05-13 |
| Summary: | summary |