The following data is part of a premarket notification filed by Heraeus Lasersonics, Inc. with the FDA for Co2 Laser And Waveguide Delivery Systems For Thor..
Device ID | K915583 |
510k Number | K915583 |
Device Name: | CO2 LASER AND WAVEGUIDE DELIVERY SYSTEMS FOR THOR. |
Classification | Powered Laser Surgical Instrument |
Applicant | HERAEUS LASERSONICS, INC. 575 COTTONWOOD DR. Milpitas, CA 95035 |
Contact | Lisa Mcgrath |
Correspondent | Lisa Mcgrath HERAEUS LASERSONICS, INC. 575 COTTONWOOD DR. Milpitas, CA 95035 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-12-13 |
Decision Date | 1992-03-27 |