Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K122567 |
Device Name |
JOULE 810/940/980 MULTI-PLATFORM SYSTEM |
Applicant |
SCITON, INC. |
925 COMMERCIAL STREET |
Palo Alto,
CA
94303
|
|
Applicant Contact |
JAY M PATEL |
Correspondent |
SCITON, INC. |
925 COMMERCIAL STREET |
Palo Alto,
CA
94303
|
|
Correspondent Contact |
JAY M PATEL |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 08/23/2012 |
Decision Date | 06/19/2013 |
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
|