Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K120622 |
Device Name |
PALOMAR VECTUS LASER |
Applicant |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
15 NETWORK DR |
BURLINGTON,
MA
01803
|
|
Applicant Contact |
Sharon Timberlake |
Correspondent |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
15 NETWORK DR |
BURLINGTON,
MA
01803
|
|
Correspondent Contact |
Sharon Timberlake |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 03/01/2012 |
Decision Date | 05/23/2012 |
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
|