Device Classification Name |
Lamp, Infrared, Therapeutic Heating
|
510(k) Number |
K120582 |
Device Name |
HEATLUX |
Applicant |
HOME SKINOVATIONS LTD. |
TAVOR BULD. POB 533 |
YOKNEAM ILLIT,
IL
20692
|
|
Applicant Contact |
AMIR WALDMAN, PH.D |
Correspondent |
HOME SKINOVATIONS LTD. |
TAVOR BULD. POB 533 |
YOKNEAM ILLIT,
IL
20692
|
|
Correspondent Contact |
AMIR WALDMAN, PH.D |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 02/27/2012 |
Decision Date | 07/06/2012 |
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
|
|
|