Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K182930 |
Device Name |
PerioLase Nd:YAG Pulsed Dental Laser System |
Applicant |
Millennium Dental Technologies, Inc. |
10945 South Street, Suite 104-A |
Cerritos,
CA
90703
|
|
Applicant Contact |
Robert H. Gregg |
Correspondent |
Millennium Dental Technologies, Inc. |
10945 South Street, Suite 104-A |
Cerritos,
CA
90703
|
|
Correspondent Contact |
Robert H. Gregg |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 10/22/2018 |
Decision Date | 07/12/2019 |
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
|