Device Classification Name |
powered light based non-laser surgical instrument with thermal effect
|
510(k) Number |
K160195 |
Device Name |
Forma System, Forma Light System |
Applicant |
FORMATK SYSTEMS LTD. |
3 HAYOZMA ST. |
TIRAT HACARMEL,
IL
3903203
|
|
Applicant Contact |
AMIT GOREN |
Correspondent |
A. STEIN - REGULATORY AFFAIRS CONSULTING LTD. |
20 HATA'AS STR..SUITE 102 |
KFAR SABA,
IL
4442520
|
|
Correspondent Contact |
AMIT GOREN |
Regulation Number | 878.4810
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/27/2016 |
Decision Date | 04/15/2016 |
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
|