The following data is part of a premarket notification filed by Jm System Co., Ltd. with the FDA for Plasmalipo/plasma D30 Lser Surgical Device.
| Device ID | K100098 |
| 510k Number | K100098 |
| Device Name: | PLASMALIPO/PLASMA D30 LSER SURGICAL DEVICE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | JM SYSTEM CO., LTD. 5401 S. COTTONWOOD CT. Greenwood Village, CO 80121 |
| Contact | Kevin Walls, Rac |
| Correspondent | Kevin Walls, Rac JM SYSTEM CO., LTD. 5401 S. COTTONWOOD CT. Greenwood Village, CO 80121 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-13 |
| Decision Date | 2010-08-13 |
| Summary: | summary |