The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Selecta Family Of Ophithalmic Laser Systems.
Device ID | K081704 |
510k Number | K081704 |
Device Name: | SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS |
Classification | Powered Laser Surgical Instrument |
Applicant | LUMENIS, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
Contact | Tina Mayer |
Correspondent | Tina Mayer LUMENIS, INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-06-17 |
Decision Date | 2008-09-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07290109143316 | K081704 | 000 |
07290109143309 | K081704 | 000 |
07290109143262 | K081704 | 000 |
07290109143255 | K081704 | 000 |
07290109145181 | K081704 | 000 |
07290109143637 | K081704 | 000 |