The following data is part of a premarket notification filed by Lumenis Ltd. with the FDA for Lumenis One Family Of Systems; Lumenis One..
| Device ID | K060448 |
| 510k Number | K060448 |
| Device Name: | LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE. |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUMENIS LTD. 2400 CONDENSA STREET Santa Clara, CA 95051 |
| Contact | Martha Murari |
| Correspondent | Martha Murari LUMENIS LTD. 2400 CONDENSA STREET Santa Clara, CA 95051 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-21 |
| Decision Date | 2006-07-06 |
| Summary: | summary |