Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K121286 |
Device Name |
EPIC 10 |
Applicant |
BIOLASE TECHNOLOGY, INC. |
4 CROMWELL |
IRVINE,
CA
92618 -1816
|
|
Applicant Contact |
ROBERT YANG |
Correspondent |
BIOLASE TECHNOLOGY, INC. |
4 CROMWELL |
IRVINE,
CA
92618 -1816
|
|
Correspondent Contact |
ROBERT YANG |
Regulation Number | 878.4810
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/30/2012 |
Decision Date | 09/28/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|