Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K122020 |
Device Name |
PHOTON PHOTON PLUS |
Applicant |
ZOLAR TECHNOLOGY & MFG. CO. INC. |
55 Northern Blvd |
Suite 200 |
Great Neck,
NY
11021
|
|
Applicant Contact |
SUSAN D GOLDSTEIN-FALK |
Correspondent |
ZOLAR TECHNOLOGY & MFG. CO. INC. |
55 Northern Blvd |
Suite 200 |
Great Neck,
NY
11021
|
|
Correspondent Contact |
SUSAN D GOLDSTEIN-FALK |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 07/10/2012 |
Decision Date | 06/05/2013 |
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
|