Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K092734 |
Device Name |
E-LIGHT LINE |
Applicant |
ESPANSIONE MARKETING S.P.A |
VIA BORGO SANTA CRISTINA, 12 |
IMOLA, BOLOGNA,
IT
40026
|
|
Applicant Contact |
GUIDO BONAPACE |
Correspondent |
ESPANSIONE MARKETING S.P.A |
VIA BORGO SANTA CRISTINA, 12 |
IMOLA, BOLOGNA,
IT
40026
|
|
Correspondent Contact |
GUIDO BONAPACE |
Regulation Number | 878.4810
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/04/2009 |
Decision Date | 09/20/2010 |
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
|
|
|