Device Classification Name |
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
|
510(k) Number |
K120080 |
Device Name |
SHASER HRS2 HAIR REMOVAL SYSTEM |
Applicant |
SHASER, INC. |
32 HARRISON ST. |
MELROSE,
MA
02176
|
|
Applicant Contact |
GLEN EMELOCK |
Correspondent |
SHASER, INC. |
32 HARRISON ST. |
MELROSE,
MA
02176
|
|
Correspondent Contact |
GLEN EMELOCK |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 01/11/2012 |
Decision Date | 05/25/2012 |
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
|