The following data is part of a premarket notification filed by Jeisys Medical Inc. with the FDA for Edgeone Co2 Laser.
| Device ID | K162169 |
| 510k Number | K162169 |
| Device Name: | EdgeOne CO2 Laser |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Jeisys Medical Inc. 307 Daeryung Techno Town 8th 81-11, Gasan-Dong, Geumcheon-Gu Seoul Seoul Teugbyeolsi, KR 153-775 |
| Contact | Erica Seo |
| Correspondent | Kathy Maynor Ronyam Enterprises LLC 26 Rebecca Ct Homosassa, FL 34446 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-03 |
| Decision Date | 2016-10-27 |
| Summary: | summary |