Device Classification Name |
Lamp, Infrared, Therapeutic Heating
|
510(k) Number |
K152461 |
Device Name |
The Time Machine Series Lasers |
Applicant |
MEDICAL LASERS MANUFACTURER INC. |
4400 ROUTE 9 SOUTH, SUITE 1000 |
FREEHOLD,
NJ
07728
|
|
Applicant Contact |
BRUCE SCHOENGOOD |
Correspondent |
MDI CONSULTANTS, INC. |
55 NORTHERN BOULEVARD |
SUITE 200 |
GREAT NECK,
NY
11021
|
|
Correspondent Contact |
Jigar Shah |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 08/28/2015 |
Decision Date | 07/08/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|