The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Scanning Laserlink.
| Device ID | K130195 |
| 510k Number | K130195 |
| Device Name: | SCANNING LASERLINK |
| Classification | Laser, Ophthalmic |
| 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 | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-28 |
| Decision Date | 2013-11-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109143545 | K130195 | 000 |