Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K150587 |
Device Name |
Cortex Laser System |
Applicant |
Cynosure, Inc. dba Ellman |
400 Karin Lane |
Hicksville,
NY
11801
|
|
Applicant Contact |
Allison Sathe |
Correspondent |
Cynosure, Inc. dba Ellman |
400 Karin Lane |
Hicksville,
NY
11801
|
|
Correspondent Contact |
Allison Sathe |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 03/09/2015 |
Decision Date | 07/21/2015 |
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
|