Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K030539 |
Device Name |
LASERSMILE |
Applicant |
BIOLASE TECHNOLOGY, INC. |
981 CALLE AMANECER |
SAN CLEMENTE,
CA
92673
|
|
Applicant Contact |
IOANA M RIZOIU |
Correspondent |
BIOLASE TECHNOLOGY, INC. |
981 CALLE AMANECER |
SAN CLEMENTE,
CA
92673
|
|
Correspondent Contact |
IOANA M RIZOIU |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 02/20/2003 |
Decision Date | 10/10/2003 |
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
|