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 |