Lamp, Infrared, Therapeutic Heating

FDA product code ILY · 207 cleared devices

Class 2 Physical Medicine

Regulation: 21 CFR 890.5500
Review panel: PM
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1985-08-21 – 2026-03-19

ILY 2026-03-19

CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)

Applicant Wuhan PHOMED Technology Company , Ltd.

K number K253965

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ILY 2025-05-19

Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)

Applicant Gigaalaser Company , Ltd.

K number K242755

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ILY 2024-10-15

SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)

Applicant Cure Point Therapeutics, Inc.

K number K231997

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ILY 2023-03-09

LED Lip Perfector, model: ZC-05

Applicant Light Tree Ventures Europe B.V.

K number K223642

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ILY 2022-08-29

OLIZ LTB-1000A

Applicant Ltbio Co., Ltd.

K number K221189

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ILY 2022-08-10

CytonPro-5000

Applicant Cytonsys, Inc.

K number K213524

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ILY 2020-12-16

dermalux Flex MD

Applicant Aesthetic Technology, Ltd.

K number K202028

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ILY 2017-07-07

AXON IR Heat Lamp

Applicant Crystal Medtech, LLC

K number K171087

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ILY 2017-06-13

HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System

Applicant Healthlight, LLC

K number K163079

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ILY 2017-05-05

Softcure 96

Applicant Wellray Medical Laser, Inc.

K number K170068

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ILY 2017-02-14

Bashan TDP Heat Lamp

Applicant Chogqing Yuhe Medical Instruments Co., Ltd.

K number K162590

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ILY 2017-01-05

Vevazz LED Heat Lamp

Applicant Vevazz, LLC

K number K162763

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ILY 2016-12-15

WS(TM) Far-Infrared Therapy Unit, Model KP-B210

Applicant Ws Far IR Medical Technology Co., Ltd.

K number K160849

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ILY 2016-07-29

HeatLux Pro II

Applicant Home Skinovations , Ltd.

K number K152087

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ILY 2016-07-26

Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3

Applicant Usa Laser Biotech, Inc.

K number K161198

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ILY 2016-07-08

The Time Machine Series Lasers

Applicant Medical Lasers Manufacturer, Inc.

K number K152461

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ILY 2016-07-05

LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System

Applicant Usa Laser Biotech, Inc.

K number K160947

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ILY 2016-07-05

LightStim Professional LED Bed

Applicant Led Intellectual Properties, LLC

K number K153399

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ILY 2016-03-30

Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)

Applicant In Light Wellness Systems, Inc.

K number K153389

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ILY 2016-03-02

BioPhotas Celluma3

Applicant Biophotas, Inc.

K number K152280

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ILY 2013-12-27

LASER-STIM

Applicant Shenzhen Dongdixin Technology Co., Ltd.

K number K131259

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ILY 2013-12-03

AVANT LASER

Applicant Avant Wellness Systems, LLC

K number K123474

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ILY 2013-10-25

BIOLIGHT BIODYNAM

Applicant Biolight AB

K number K130866

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ILY 2013-10-10

3B LASER NEEDLE

Applicant Livetec GmbH

K number K131797

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ILY 2013-07-03

STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM

Applicant Laserstim, Inc.

K number K123177

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ILY 2013-05-02

CYNOSURE 1064NM DIODE LASER

Applicant Cynosure, Inc.

K number K123971

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ILY 2013-05-01

TENDER TOUCH

Applicant Sometech Corporation

K number K121401

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ILY 2013-01-25

ASA LASER SH1

Applicant El.En Electronic Engineering Spa

K number K122125

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ILY 2013-01-03

BIOPHOTAS LIFELIGHT

Applicant Biophotas, Inc.

K number K122237

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ILY 2012-11-23

DIOWAVE LOW LEVEL COLD LASER SYSTEM

Applicant Technological Medical Advancments, Inc. (Tma)

K number K121363

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ILY 2012-07-12

CS1000 LIGHT THERAPY DEVICE

Applicant Genesis Health Light Corporation

K number K110558

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ILY 2012-07-06

HEATLUX

Applicant Home Skinovations , Ltd.

K number K120582

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ILY 2012-06-19

HEALITE II SYSTEM

Applicant Lutronic Corporation

K number K113668

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ILY 2012-06-12

LITECURE THERAPY COMPACT

Applicant Litecure, LLC

K number K121487

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ILY 2012-05-25

K-LASER

Applicant Eltech S.R.L

K number K120604

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ILY 2012-05-16

VARAYA AR , VARAYA SPORT

Applicant Varaya Photoceuticals, LLC

K number K112494

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ILY 2012-03-06

THERASAGE HEATING PAD

Applicant Therasage Corporation

K number K120254

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ILY 2012-02-27

WARP10,WARP75

Applicant Quantum Devices, Inc.

K number K113231

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ILY 2012-02-10

L-SER KO LAMP

Applicant Ya-Man, Ltd.

K number K112016

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ILY 2012-02-09

DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBE

Applicant Dynatronics Corp.

K number K113250

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ILY 2011-11-09

ASA 'MPHI FAMILY DIODE LASER

Applicant Cynosure, Inc.

K number K111901

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ILY 2011-08-22

YOLO CURVE

Applicant Yolo Medical, Inc.

K number K110342

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ILY 2011-03-30

GAUNYING INFRARED LAMP

Applicant Foshan Gaunying Electronics Co., Ltd.

K number K110721

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ILY 2011-02-25

LUCIA

Applicant Meridian Co., Ltd.

K number K102375

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ILY 2011-02-17

NEXUS BIOWAVE 7W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 10W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 30W PRO IR LAMP SYSTEM, NEXUS

Applicant Usa Laser Biotech, Inc.

K number K101893

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ILY 2011-01-25

LITECURE THERAPY SYSTEM

Applicant Litecure, LLC

K number K103511

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ILY 2011-01-21

HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT

Applicant Bioremedi Therapeutic Systems, Inc.

K number K101894

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ILY 2011-01-11

HVR PAIN RELIEF DEVICE

Applicant H.V.R., Inc.

K number K101716

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ILY 2011-01-05

GAUNYING INFRARED LAMP MODEL IL50

Applicant Foshan Gaunying Electronics Co., Ltd.

K number K101693

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ILY 2010-12-23

MODEL LA-1200 MULTI-CHANNEL LASER THERAPY SYSTEM

Applicant United Integrated Services Co., Ltd.

K number K102134

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ILY 2010-12-03

PREMIO 10 MOXA

Applicant Sedatelec

K number K101267

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ILY 2010-10-04

LUMANOSITY CELEBRITY, MODEL 204

Applicant Lumanosity, Inc.

K number K100213

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ILY 2010-08-23

INNOVATIVE MED MULTI WAVE LIGHT THERAPY SYSTEM

Applicant Innovative Med, Inc.

K number K093204

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ILY 2010-08-13

GAUNYING INFRARED LAMP

Applicant Foshan Gaunying Electronics Co., Ltd.

K number K102149

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ILY 2010-06-23

BACK-TEK

Applicant York Biomedical, Inc.

K number K101227

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ILY 2010-02-11

ELECTRO-LIGHT THERAPY

Applicant Hill Laboratories Co.

K number K090250

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ILY 2010-01-28

THERMOTEX PLATINUM SYSTEM

Applicant Eas Consulting Group, LLC

K number K092589

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ILY 2009-12-15

LASERPEN PRACTISE AND EXPERT, HANDYLASER SPRINT, HANDYLASER TRION, PHYSIOLASER OLYMPIC, POLYLASER

Applicant Reimers and Janssen GmbH

K number K091675

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ILY 2009-10-28

NEXUS XPULSE 805 IR LAMP SYSTEM, NEXUS XPULSE 980 IR LAMP SYSTEM, MODEL 805, 980

Applicant Usa Laser Biotech, Inc.

K number K091726

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ILY 2009-10-15

TANDA RESTORE, MODEL PTSCS

Applicant Pharos Life Corporation

K number K090008

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ILY 2009-08-20

THERMAPULSE

Applicant Palomar Medical Products, Inc.

K number K092222

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ILY 2009-08-19

K-LASER K-1200, MODEL 12 W

Applicant Eltech S.R.L

K number K091497

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ILY 2009-08-10

SCALAR WAVE LASER SYSTEM

Applicant Stellar Lasers

K number K091158

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ILY 2009-07-28

AL T LASER, MODEL AVI HPLL-12

Applicant Avicenna Laser Technology, Inc.

K number K091285

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ILY 2009-07-16

AKLARUS PHOTOTHERAPY SYSTEM

Applicant Hill Laboratories Co.

K number K083183

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ILY 2009-06-22

ANTI-WRINKLE LIGHT, MODEL 1302 AND PAIN THERAPY LIGHT, MODEL 1301

Applicant Led Intellectual Properties, LLC

K number K083580

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ILY 2009-06-16

PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS

Applicant Prime Herbs Corporation

K number K081720

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ILY 2009-05-11

MULTI-CHANNEL LASER THERAPY SYSTEM

Applicant United Integrated Services Co., Ltd.

K number K082686

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ILY 2009-04-21

NEUTROLUMENPN SYSTEM, MODEL 1000

Applicant Neurolumen, LLC

K number K082223

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ILY 2009-04-14

EZLASE

Applicant Biolase Technology, Inc.

K number K083595

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ILY 2008-12-29

LAPEX BCS

Applicant Meridian Co., Ltd.

K number K081962

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ILY 2008-12-18

BIOFLEX LD-R100 TREATMENT HEAD

Applicant Meditech International, Inc.

K number K081355

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ILY 2008-12-11

EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X

Applicant Lighthouse Technical Innovations, Inc.

K number K083560

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ILY 2008-12-09

NANOBEAM 940, MODEL 940-900-02

Applicant Davaray, Inc.

K number K073681

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ILY 2008-11-19

THERAGEM PROFESSIONAL T1002

Applicant Medica Health, Ltd.

K number K081505

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ILY 2008-11-07

DPL THERAPY SYSTEM

Applicant Led Technologies, LLC

K number K081570

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ILY 2008-10-23

LUMINEX INFRARED LAMP SYSTEM

Applicant Medical Laser Systems, Inc.

K number K082969

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ILY 2008-10-03

ML830TP

Applicant Microlight Corporation of America

K number K080786

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ILY 2008-10-01

MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER

Applicant Medx Electronics, Inc.

K number K082707

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ILY 2008-08-20

TQ SOLO AND SOLO PRO AND LS50 ACCESSORY AND MR4 MULTI RADIANCE THERAPY SYSTEM

Applicant Escada International, Inc.

K number K080102

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ILY 2008-08-11

WEBERNEEDLE BASIC LASER

Applicant Weber Medical GmbH

K number K073352

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ILY 2008-07-18

WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES

Applicant Ws Far IR Medical Technology Co., Ltd.

K number K080465

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ILY 2008-07-09

SPECTRA THERAPY SYSTEM A1000 LASER DEVICE

Applicant Premier Dynamics, Inc.

K number K080689

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ILY 2008-05-23

DEL SOL RED LIGHT THERAPY SYSTEM

Applicant Edge Systems, Inc.

K number K072399

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ILY 2008-04-21

CELL GEN LASER, MODEL CG-4000

Applicant Cell Gen Therapeutics, LLC

K number K080084

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ILY 2008-03-07

ALMA LASER NIR MODULE

Applicant Alma Lasers , Ltd.

K number K080318

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ILY 2007-11-16

LUMACARE MODEL LC-122M NON-COHERENT LIGHT SOURCE AND MODEL LUM-P FIBRE OPTIC PROBE

Applicant Lynton Lasers Limited

K number K072048

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ILY 2007-11-16

THE LIFE VESSEL

Applicant Cottonwood Vessel Corporation

K number K070690

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ILY 2007-10-29

TERRAQUANT MQ2000 V.5 WITH THE TQ-1TENS

Applicant Escada International, Inc.

K number K071445

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ILY 2007-08-28

RAINBOW, RAINBOW LIGHT,RAINBOW BLUE, RAINBOW PLUS

Applicant Rainbow Communications, Inc.

K number K070338

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ILY 2007-07-02

POWERLASER

Applicant Powermedic Aps

K number K070516

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ILY 2007-05-24

LIGHT RELIEF, MODEL LR150, LR200

Applicant Light Relief, LLC

K number K070974

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ILY 2007-05-16

THOR VR SINGLE DIODE LASER TREATMENT PROBE, MODEL 200 MW SINGLE VR DIODE PROBE

Applicant Thor International

K number K070024

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ILY 2007-04-23

MEDILASER, MODEL 1000

Applicant Laser Thera, LLC

K number K063745

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ILY 2007-03-22

HWATO TDP HEAT LAMP, MODELS TDP11-DL, TDP12-XL AND TDP-22XL

Applicant Suzhou Medical Appliance Factory

K number K063568

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ILY 2007-02-28

LC THERAPY, MODEL LCT-1000

Applicant Litecure, LLC

K number K070400

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ILY 2006-12-19

MODEL 2200

Applicant Clarimedex, Inc.

K number K062635

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ILY 2006-12-01

ILLUMIMED

Applicant Photoactif, LLC

K number K060792

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ILY 2006-10-06

TERRAQUANT MQ2000 V. 5 AND HANDYRX MQ2007 LASERS

Applicant Escada International, Inc.

K number K061614

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ILY 2006-09-29

ACUMED LASER, MODEL 1000

Applicant Laser Thera, LLC

K number K060153

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