K153769 is an FDA 510(k) clearance for the R:GEN Laser System. This device is classified as a Laser, Ophthalmic (Class II - Special Controls, product code HQF).
Submitted by Lutronic Corporation (Goyang-Si, KR). The FDA issued a Cleared decision on October 5, 2016, 280 days after receiving the submission on December 30, 2015.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.
| 510(k) Number | K153769 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 2015 |
| Decision Date | October 05, 2016 |
| Days to Decision | 280 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 |