Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K043251 |
Device Name |
CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B |
Applicant |
CANDELA CORP. |
530 BOSTON POST RD. |
WAYLAND,
MA
01778
|
|
Applicant Contact |
LORRAINE CALZETTA |
Correspondent |
CANDELA CORP. |
530 BOSTON POST RD. |
WAYLAND,
MA
01778
|
|
Correspondent Contact |
LORRAINE CALZETTA |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 11/23/2004 |
Decision Date | 02/09/2005 |
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
|