Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K162454 |
Device Name |
PicoWay Laser System |
Applicant |
SYNERON CANDELA CORPORATION |
530 BOSTON POST ROAD |
Wayland,
MA
01778
|
|
Applicant Contact |
Ruthie Amir |
Correspondent |
HOGAN LOVELLS US LLP |
1835 MARKET ST |
29TH FLOOR |
PHILADELPHIA,
PA
19103
|
|
Correspondent Contact |
Janice M. Hogan |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 09/01/2016 |
Decision Date | 02/01/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02592993
|
Reviewed by Third Party |
No
|
Combination Product |
No
|