The following data is part of a premarket notification filed by Lasering S.r.l. with the FDA for Velure Family Of Diode Lasers And Delivery Device Accessories.
| Device ID | K063396 |
| 510k Number | K063396 |
| Device Name: | VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIES |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LASERING S.R.L. 2246 CAMINO RAMON San Ramon, CA 94583 |
| Contact | Allen R Howes |
| Correspondent | Allen R Howes LASERING S.R.L. 2246 CAMINO RAMON San Ramon, CA 94583 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-09 |
| Decision Date | 2007-01-17 |
| Summary: | summary |