| Device |
lamp, infrared, therapeutic heating |
| Regulation Description |
Infrared lamp. |
| Product Code | ILY |
| Regulation Number |
890.5500
|
|---|
| Device Class |
2
|
| Premarket Reviews |
|---|
| Manufacturer | Decision |
|---|
|
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| ALMA LASERS LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| ALTUS MEDICA |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| APOLLO CORP. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| BALLARD MEDICAL PRODUCTS |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| BIOLASE TECHNOLOGY, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| BOSTON SCIENTIFIC CORP. |
| |
SUBSTANTIALLY EQUIVALENT
|
4 |
| CELL GEN |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| CHATTANOOGA GROUP |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| CHUNG CHENG ELECTRIC HEATING CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| CLARIMEDEX, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| COTTONWOOD VESSEL CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| CURAE'LASE INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| CUTERA, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| CYNOSURE, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
4 |
| DIOMEDICS, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| DYNATRONICS CORP. |
| |
SUBSTANTIALLY EQUIVALENT
|
4 |
| EL.EN. ELECTRONIC ENGINEERING SPA |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| ELTECH, S.R.L. |
| |
SUBSTANTIALLY EQUIVALENT
|
2 |
| FISHER & PAYKEL HEALTHCARE LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
2 |
| HEALTHTEAM |
| |
SUBSTANTIALLY EQUIVALENT
|
2 |
| HELIO MEDICAL SUPPLIES, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| HILL LABORATORIES CO. |
| |
SUBSTANTIALLY EQUIVALENT
|
2 |
| HOME SKINOVATIONS LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| LASER THERA, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
2 |
| LED INTELLECTUAL PROPERTIES, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| LED TECHNOLOGIES, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| LIFE WITHOUT PAIN, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| LIGHTHOUSE TECHNICAL INNOVATIONS, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| LITECURE, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
3 |
| LUTRONIC CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| LYNTON LASERS LIMITED |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| MEDICAL LASER SYSTEMS INC |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| MEDX |
| |
SUBSTANTIALLY EQUIVALENT
|
4 |
| MERIDIAN CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
2 |
| METTLER ELECTRONICS CORP. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| MICROLIGHT CORPORATION OF AMERICA |
| |
SUBSTANTIALLY EQUIVALENT
|
2 |
| NEW STAR LASERS, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| OLYMPUS |
| |
SUBSTANTIALLY EQUIVALENT
|
2 |
| OMNILIGHT, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| PALOMAR MEDICAL TECHNOLOGIES, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
3 |
| PHAROS LIFE CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| PHOTO THERAPEUTICS LIMITED |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| POWERMEDIC APS |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| PREMIER DYNAMICS, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| PRIME HERBS CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| QUANTUM |
| |
SUBSTANTIALLY EQUIVALENT
|
2 |
| RAINBOW COMMUNICATIONS, INC |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| RICH-MAR CORP. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| SOMETECH CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| SUZHOU MEDICAL APPLIANCE FACTORY |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| THOR INTERNATIONAL |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
| UNITED INTEGRATED SERVICES CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
2 |
| WS FAR IR MEDICAL TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1 |
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
| Class I |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class II |
0 |
0 |
1 |
1 |
0 |
1 |
0 |
| Class III |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
