The following data is part of a premarket notification filed by Jm System Co., Ltd. with the FDA for Edge Co2 Laser System.
| Device ID | K100590 |
| 510k Number | K100590 |
| Device Name: | EDGE CO2 LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument With Microbeam\fractional Output |
| Applicant | JM SYSTEM CO., LTD. 410 DAERUNG TECHNO TOWN 8TH GASAN-DONG Geumchen-gu, Seoul,, KR 153-77 |
| Contact | Su-gun Lee |
| Correspondent | Su-gun Lee JM SYSTEM CO., LTD. 410 DAERUNG TECHNO TOWN 8TH GASAN-DONG Geumchen-gu, Seoul,, KR 153-77 |
| Product Code | ONG |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-02 |
| Decision Date | 2010-11-10 |
| Summary: | summary |