Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K151763 |
Device Name |
PerioLase Nd:YAG Pulsed Dental Laser System |
Applicant |
MILLENNIUM DENTAL TECHNOLOGIES, INC. |
10945 SOUTH ST., SUITE 104-A |
CERRITOS,
CA
90703
|
|
Applicant Contact |
DAVID M HARRIS |
Correspondent |
MILLENNIUM DENTAL TECHNOLOGIES, INC. |
10945 SOUTH ST., SUITE 104-A |
CERRITOS,
CA
90703
|
|
Correspondent Contact |
DAVID M HARRIS |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 06/29/2015 |
Decision Date | 03/15/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|