ILY · Class II · 21 CFR 890.5500

FDA Product Code ILY: Lamp, Infrared, Therapeutic Heating

Leading manufacturers include Usa Laser Biotech, Inc., Escada International, Inc. and Medx Electronics, Inc..

229
Total
229
Cleared
168d
Avg days
1985
Since
229 devices
73–96 of 229
Cleared Dec 03, 2010
PREMIO 10 MOXA
K101267
Sedatelec
Physical Medicine · 212d
Cleared Oct 04, 2010
LUMANOSITY CELEBRITY, MODEL 204
K100213
Lumanosity, Inc.
Physical Medicine · 252d
Cleared Aug 23, 2010
INNOVATIVE MED MULTI WAVE LIGHT THERAPY SYSTEM
K093204
Innovative Med, Inc.
Physical Medicine · 314d
Cleared Aug 13, 2010
GAUNYING INFRARED LAMP
K102149
Foshan Gaunying Electronics Co., Ltd.
Physical Medicine · 14d
Cleared Jun 23, 2010
BACK-TEK
K101227
York Biomedical, Inc.
Physical Medicine · 51d
Cleared Feb 11, 2010
ELECTRO-LIGHT THERAPY
K090250
Hill Laboratories Co.
Physical Medicine · 374d
Cleared Jan 28, 2010
THERMOTEX PLATINUM SYSTEM
K092589
Eas Consulting Group, LLC
Physical Medicine · 157d
Cleared Dec 15, 2009
LASERPEN PRACTISE AND EXPERT, HANDYLASER SPRINT, HANDYLASER TRION, PHYSIOLASER OLYMPIC, POLYLASER
K091675
Reimers and Janssen GmbH
Physical Medicine · 189d
Cleared Oct 28, 2009
NEXUS XPULSE 805 IR LAMP SYSTEM, NEXUS XPULSE 980 IR LAMP SYSTEM, MODEL 805, 980
K091726
Usa Laser Biotech, Inc.
Physical Medicine · 139d
Cleared Oct 15, 2009
TANDA RESTORE, MODEL PTSCS
K090008
Pharos Life Corporation
Physical Medicine · 286d
Cleared Aug 20, 2009
THERMAPULSE
K092222
Palomar Medical Products, Inc.
Physical Medicine · 28d
Cleared Aug 19, 2009
K-LASER K-1200, MODEL 12 W
K091497
Eltech S.R.L
Physical Medicine · 91d
Cleared Aug 10, 2009
SCALAR WAVE LASER SYSTEM
K091158
Stellar Lasers
Physical Medicine · 111d
Cleared Jul 28, 2009
AL T LASER, MODEL AVI HPLL-12
K091285
Avicenna Laser Technology, Inc.
Physical Medicine · 88d
Cleared Jul 16, 2009
AKLARUS PHOTOTHERAPY SYSTEM
K083183
Hill Laboratories Co.
Physical Medicine · 261d
Cleared Jun 22, 2009
ANTI-WRINKLE LIGHT, MODEL 1302 AND PAIN THERAPY LIGHT, MODEL 1301
K083580
Led Intellectual Properties, LLC
Physical Medicine · 201d
Cleared Jun 16, 2009
PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS
K081720
Prime Herbs Corporation
Physical Medicine · 363d
Cleared May 11, 2009
MULTI-CHANNEL LASER THERAPY SYSTEM
K082686
United Integrated Services Co., Ltd.
Physical Medicine · 238d
Cleared Apr 21, 2009
NEUTROLUMENPN SYSTEM, MODEL 1000
K082223
Neurolumen, LLC
Physical Medicine · 258d
Cleared Apr 14, 2009
EZLASE
K083595
Biolase Technology, Inc.
Physical Medicine · 130d
Cleared Dec 29, 2008
LAPEX BCS
K081962
Meridian Co., Ltd.
Physical Medicine · 173d
Cleared Dec 18, 2008
BIOFLEX LD-R100 TREATMENT HEAD
K081355
Meditech International, Inc.
Physical Medicine · 218d
Cleared Dec 11, 2008
EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X
K083560
Lighthouse Technical Innovations, Inc.
Physical Medicine · 9d
Cleared Dec 09, 2008
NANOBEAM 940, MODEL 940-900-02
K073681
Davaray, Inc.
Physical Medicine · 347d