The following data is part of a premarket notification filed by General Project S.r.l. with the FDA for Med Flash Ii Intense Pulsed Light System..
| Device ID | K051508 |
| 510k Number | K051508 |
| Device Name: | MED FLASH II INTENSE PULSED LIGHT SYSTEM. |
| Classification | Powered Laser Surgical Instrument |
| Applicant | GENERAL PROJECT S.R.L. 5 TIMBER LANE North Reading, MA 01864 |
| Contact | Maureen O'connell |
| Correspondent | Maureen O'connell GENERAL PROJECT S.R.L. 5 TIMBER LANE North Reading, MA 01864 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-07 |
| Decision Date | 2005-10-05 |
| Summary: | summary |