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
25–48 of 229
Cleared Jun 08, 2015
ZX2 Laser System
K150466
Lzr7, Inc.
Physical Medicine · 105d
Cleared Mar 31, 2015
HeatLux Pro I
K150175
Home Skinovations , Ltd.
Physical Medicine · 64d
Cleared Jan 28, 2015
QK-SYSTEMIC THERAPEUTIC APPARATUS
K141892
Harbin Quanke Medi-Technical Development Co., Ltd.
Physical Medicine · 198d
Cleared Jan 21, 2015
NEUROLUMEN PN-1000
K142025
Neurolumen, LLC
Physical Medicine · 180d
Cleared Jan 13, 2015
3B Laser 500, 3B Laser 200, LA-X P 500, LA-X P 200
K142722
Livetec GmbH
Physical Medicine · 112d
Cleared Jan 07, 2015
HILTHERA 4.0
K141861
Jeisys Medical, Inc.
Physical Medicine · 181d
Cleared Jan 07, 2015
Applied BioPhotonics Phototherapy System ABPT1003
K142256
Applied Biophotonics , Ltd.
Physical Medicine · 146d
Cleared Dec 02, 2014
Infrared Therapy System
K142340
Beijing Huatai Healthcare Technology Co., Ltd.
Physical Medicine · 103d
Cleared Nov 07, 2014
Power Twin21-50/Power Twin21-100
K142215
Livetec GmbH
Physical Medicine · 87d
Cleared Oct 30, 2014
VELASII THERAPY LASER SYSTEM
K142078
Aspen Laser Systems, LLC
Physical Medicine · 91d
Cleared Oct 24, 2014
OPTON PRO
K141564
Zimmer Medizinsystems GmbH
Physical Medicine · 134d
Cleared Sep 03, 2014
INFRARED HEATING DEVICE
K140865
Pro Medical Supplies, Inc.
Physical Medicine · 153d
Cleared Jun 13, 2014
PHYSIOLASER OLYMPIC, SINGLE PROBES CW, CLUSTER PROBES CW, LIGHT NEEDLE, PHOTONIC SATELLITE
K131080
Reimers and Janssen GmbH
Physical Medicine · 445d
Cleared Jun 02, 2014
LUMIX 3 PLUS AND LUMIX 3 ULTRA SYSTEM
K132016
Texas Applied Biomedical Services, Inc.
Physical Medicine · 336d
Cleared May 12, 2014
GALLIEON-1 MEDICAL LASER
K132529
Future Device and Technology, Inc.
Physical Medicine · 273d
Cleared May 02, 2014
GIGALASER
K134017
Powermedic Aps
Physical Medicine · 123d
Cleared Jan 15, 2014
BIOPHOTAS CELLUMA
K131113
Biophotas, Inc.
Physical Medicine · 268d
Cleared Jan 10, 2014
CL10009 IR LASER
K130168
Curae'Lase, Inc.
Physical Medicine · 351d
Cleared Dec 27, 2013
LASER-STIM
K131259
Shenzhen Dongdixin Technology Co., Ltd.
Physical Medicine · 239d
Cleared Dec 03, 2013
AVANT LASER
K123474
Avant Wellness Systems, LLC
Physical Medicine · 385d
Cleared Oct 25, 2013
BIOLIGHT BIODYNAM
K130866
Biolight AB
Physical Medicine · 211d
Cleared Oct 10, 2013
3B LASER NEEDLE
K131797
Livetec GmbH
Physical Medicine · 114d
Cleared Jul 03, 2013
STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM
K123177
Laserstim, Inc.
Physical Medicine · 267d
Cleared May 02, 2013
CYNOSURE 1064NM DIODE LASER
K123971
Cynosure, Inc.
Physical Medicine · 127d