510(k) K130195 ยท HQF Laser, Ophthalmic
SCANNING LASERLINK
| Applicant | Lumenis, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Nov 1, 2013 |
| Received | Jan 28, 2013 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K130195
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2014 | Lumenis, Inc. Array LaserLink, Manufactured by Lumenis,
The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocular pathology. " For the Posterior Segment, the Array" LaserLink" Terminated |
HQF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.