Device Classification Name |
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
|
510(k) Number |
K150051 |
Device Name |
Exilite |
Applicant |
BTL Industries, Inc. |
47 Loring Drive |
Framingham,
MA
01702
|
|
Applicant Contact |
Jan Zarsky |
Correspondent |
BTL Industries, Inc. |
47 Loring Drive |
Framingham,
MA
01702
|
|
Correspondent Contact |
Jan Zarsky |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 01/12/2015 |
Decision Date | 04/08/2015 |
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
|