The following data is part of a premarket notification filed by Lumenis Inc. with the FDA for Vision One Laser System.
| Device ID | K111213 |
| 510k Number | K111213 |
| Device Name: | VISION ONE LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LUMENIS INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Contact | Jace R Mclane |
| Correspondent | Jace R Mclane LUMENIS INC. 3959 WEST 1820 SOUTH Salt Lake City, UT 84104 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-02 |
| Decision Date | 2011-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109143286 | K111213 | 000 |
| 00810096330352 | K111213 | 000 |
| 00810096330147 | K111213 | 000 |
| 00810096330130 | K111213 | 000 |
| 00810096330123 | K111213 | 000 |
| 00810096330116 | K111213 | 000 |
| 00810096330109 | K111213 | 000 |
| 00810096330093 | K111213 | 000 |
| 00810096330086 | K111213 | 000 |