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 |