The following data is part of a premarket notification filed by Lutronic Corporation with the FDA for R:gen Laser System.
| Device ID | K153769 |
| 510k Number | K153769 |
| Device Name: | R:GEN Laser System |
| Classification | Laser, Ophthalmic |
| Applicant | Lutronic Corporation 219, Sowon-ro, Deogyang-gu Goyang-si, KR 410-220 |
| Contact | Jhung Won Vojir |
| Correspondent | Jhung Won Vojir Lutronic, Inc. 6 Neshaminy Interplex, Suite 100 Trevose, PA 19053 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-30 |
| Decision Date | 2016-10-05 |
| Summary: | summary |