Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K082721 |
Device Name |
LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMS |
Applicant |
PHOTOMEDEX, INC. |
147 KEYSTONE DR. |
MONTGOMERYVILLE,
PA
18936
|
|
Applicant Contact |
ALFRED INTINTOLI |
Correspondent |
PHOTOMEDEX, INC. |
147 KEYSTONE DR. |
MONTGOMERYVILLE,
PA
18936
|
|
Correspondent Contact |
ALFRED INTINTOLI |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 09/17/2008 |
Decision Date | 10/28/2008 |
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
|
Recalls |
CDRH Recalls
|