K130195 is an FDA 510(k) clearance for the SCANNING LASERLINK. This device is classified as a Laser, Ophthalmic (Class II - Special Controls, product code HQF).
Submitted by Lumenis, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on November 1, 2013, 277 days after receiving the submission on January 28, 2013.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.
| 510(k) Number | K130195 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 2013 |
| Decision Date | November 01, 2013 |
| Days to Decision | 277 days |
| Submission Type | Abbreviated |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQF - Laser, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4390 |