Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K013043 |
Device Name |
CANDELA CLEARBEAM PULSED DYE LASER |
Applicant |
CANDELA CORP. |
530 BOSTON POST RD. |
WAYLAND,
MA
01778
|
|
Applicant Contact |
JOAN CLIFFORD |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
DONALD J SHERRATT |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 09/10/2001 |
Decision Date | 10/11/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|