Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K083927 |
Device Name |
WATERLASE MD |
Applicant |
BIOLASE TECHNOLOGY, INC. |
4 CROMWELL |
IRVINE,
CA
92618 -1816
|
|
Applicant Contact |
IOANNA RIZOU |
Correspondent |
BIOLASE TECHNOLOGY, INC. |
4 CROMWELL |
IRVINE,
CA
92618 -1816
|
|
Correspondent Contact |
IOANNA RIZOU |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 12/31/2008 |
Decision Date | 10/01/2009 |
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
|