The following data is part of a premarket notification filed by Lasering S.r.l. with the FDA for Slim Evolution Family Of Co2 Lasers And Delivery Device Accessories.
Device ID | K063001 |
510k Number | K063001 |
Device Name: | SLIM EVOLUTION FAMILY OF CO2 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 | 2006-10-02 |
Decision Date | 2007-03-07 |
Summary: | summary |