ILY · Class II · 21 CFR 890.5500

FDA Product Code ILY: Lamp, Infrared, Therapeutic Heating

Leading manufacturers include Dynatronics Corp., Cynosure, Inc. and Usa Laser Biotech, Inc..

229
Total
229
Cleared
168d
Avg days
1985
Since
229 devices
97–120 of 229
Cleared Dec 13, 2004
ML830 LASER SYSTEM
K041364
Microlight Corporation of America
Physical Medicine · 206d
Cleared Dec 13, 2004
BIOCARE SYSTEMS PREMIR 818
K042532
Biocare Systems, Inc.
Physical Medicine · 87d
Cleared Nov 17, 2004
IR HEAT LAMP SYSTEMS: ICL 15 HFPL SYSTEM, ICL 60 PLUS HFPL SYSTEM (MODELS 40, 100 AND 250), ICL 100 ACTIVO SCANNER SYSTE
K042256
Usa Laser Biotech, Inc.
Physical Medicine · 89d
Cleared Oct 18, 2004
CUTERA TABLETOP AESTHETIC PRODUCT
K042165
Cutera, Inc.
Physical Medicine · 68d
Cleared Jun 02, 2004
SOLARIS D890 THERAPY PROBE
K040729
Dynatronics Corp.
Physical Medicine · 72d
Cleared May 07, 2004
RICH-MAR AUTOPRISM INFRARED LAMP
K040679
Rich-Mar Corp.
Physical Medicine · 53d
Cleared Jun 04, 2003
PALOMAR LIGHTCUBE
K024179
Palomar Medical Products, Inc.
Physical Medicine · 168d
Cleared Mar 06, 2003
SURGICAL PATIENT WARMER, MODEL PW820 JHU
K022609
Fisher &Paykel Healthcare , Ltd.
Physical Medicine · 212d
Cleared Sep 29, 2000
OLYMPIC WARM-UP
K001056
Olympic Medical Corp.
Physical Medicine · 179d
Cleared Jul 19, 2000
SPINAL PAD
K993684
Bioscan, Inc.
Physical Medicine · 261d
Cleared Jul 18, 2000
BIOPACK
K993685
Bioscan, Inc.
Physical Medicine · 260d
Cleared Jul 18, 2000
LIGHT PATCH
K993686
Bioscan, Inc.
Physical Medicine · 260d
Cleared Dec 17, 1999
QK-WIDE BAND SPECTRUM THERAPEUTIC APPARATUS, MODELS CO1A, CO1B, CO1C, CO1D, CO2A, CO2B
K993123
United Pacific Co., Ltd.
Physical Medicine · 88d
Cleared Oct 27, 1999
ST-302 INFRAREX
K990233
Skylark Device Co., Ltd.
Physical Medicine · 275d
Cleared Jul 28, 1999
SACRED CRANE TDP LAMP, MODELS CQ-27, CQ-12, CQ-36
K991503
United Pacific Co., Ltd.
Physical Medicine · 90d
Cleared Oct 26, 1998
PATIENT WARMER- MODEL PW810
K982636
Fisher &Paykel Healthcare , Ltd.
Physical Medicine · 89d
Cleared Sep 22, 1998
PHASER-2000
K982546
Diomedics, Inc.
Physical Medicine · 63d
Cleared Jun 22, 1998
PHOTONIC STIMULATOR
K974468
Bales Scientific, Inc.
Physical Medicine · 208d
Cleared Apr 03, 1998
DERMATHERM 100
K980607
New Star Lasers, Inc.
Physical Medicine · 45d
Cleared Nov 04, 1997
THERAPIK
K964397
The Jenex Corporation
Physical Medicine · 365d
Cleared Jun 13, 1997
N/A
K970590
North American Technical Services Corp.
Physical Medicine · 115d
Cleared Jun 13, 1997
N/A
K970592
North American Technical Services Corp.
Physical Medicine · 115d
Cleared May 09, 1997
WS FREQUENCY SPECTRUM EFFECT PHYSIATRICS APPARATUS
K954577
C.A.I. Industries Corp.
Physical Medicine · 585d
Cleared Dec 12, 1996
THE SPECIAL ELECTROMAGNETIC THERAPEUTIC APPARATUS
K963728
China Chongqing Bashan Instrument Factory
Physical Medicine · 86d