The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Family Of Selecta Laser Systems Including Selecta 1064, Selecta Slt, Selecta Duet, Selecta Duo, Selecta Trio.
| Device ID | K060338 |
| 510k Number | K060338 |
| Device Name: | FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUMENIS, INC. 2400 CONDENSA ST. Santa Clara, CA 95051 -0901 |
| Contact | Connie Hoy |
| Correspondent | Connie Hoy 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 | 2006-02-10 |
| Decision Date | 2006-03-09 |
| Summary: | summary |