The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Family Of Selecta Ophthalmic Laser Systems (selecta 1064, Selecta Slt, Selecta Duo), Delivery Device And Accessories.
| Device ID | K051944 |
| 510k Number | K051944 |
| Device Name: | FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES |
| Classification | Laser, Ophthalmic |
| 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 | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-18 |
| Decision Date | 2005-09-30 |
| Summary: | summary |