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 |