K051944 is an FDA 510(k) clearance for the FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES. This device is classified as a Laser, Ophthalmic (Class II - Special Controls, product code HQF).
Submitted by Lumenis, Inc. (Santa Clara, US). The FDA issued a Cleared decision on September 30, 2005, 74 days after receiving the submission on July 18, 2005.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.
| 510(k) Number | K051944 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2005 |
| Decision Date | September 30, 2005 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQF - Laser, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4390 |