K190083 is an FDA 510(k) clearance for the Leaf Photocoagulator. This device is classified as a Laser, Ophthalmic (Class II - Special Controls, product code HQF).
Submitted by Norlase Aps (Ballerup, DK). The FDA issued a Cleared decision on May 3, 2019, 106 days after receiving the submission on January 17, 2019.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.
| 510(k) Number | K190083 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 2019 |
| Decision Date | May 03, 2019 |
| Days to Decision | 106 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 |