Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K050673 |
Device Name |
CANDELA FAMILY OF PULSE DYE LASER SYSTEMS |
Applicant |
CANDELA CORP. |
530 BOSTON POST RD. |
WAYLAND,
MA
01886
|
|
Applicant Contact |
LORRAINE CALZETTA PATROVIC |
Correspondent |
CANDELA CORP. |
530 BOSTON POST RD. |
WAYLAND,
MA
01886
|
|
Correspondent Contact |
LORRAINE CALZETTA PATROVIC |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 03/15/2005 |
Decision Date | 06/13/2005 |
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
|
Recalls |
CDRH Recalls
|