Atlas FDA

ILY

229 FDA 510(k) clearances · Product code

151 daysmedian time to decision
286 days90th percentile
229clearances measured

FDA profile

Official device name
Lamp, Infrared, Therapeutic Heating
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5500
Medical specialty
Physical Medicine
Adverse events (MAUDE)
2012: 7 · 2013: 8 · 2017: 12 · 2023: 15 · 2024: 19 · 2026: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.) (K253965)Wuhan PHOMED Technology Company , Ltd.2026-03-19
Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) (K242755)Gigaalaser Company , Ltd.2025-05-19
SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) (K231997)Cure Point Therapeutics, Inc.2024-10-15
LED Lip Perfector, model: ZC-05 (K223642)Light Tree Ventures Europe B.V.2023-03-09
OLIZ LTB-1000A (K221189)Ltbio Co., Ltd.2022-08-29
CytonPro-5000 (K213524)Cytonsys, Inc.2022-08-10
dermalux Flex MD (K202028)Aesthetic Technology, Ltd.2020-12-16
AXON IR Heat Lamp (K171087)Crystal Medtech, LLC2017-07-07
HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System (K163079)Healthlight, LLC2017-06-13
Softcure 96 (K170068)Wellray Medical Laser, Inc.2017-05-05
Bashan TDP Heat Lamp (K162590)Chogqing Yuhe Medical Instruments Co., Ltd.2017-02-14
Vevazz LED Heat Lamp (K162763)Vevazz, LLC2017-01-05
WS(TM) Far-Infrared Therapy Unit, Model KP-B210 (K160849)Ws Far IR Medical Technology Co., Ltd.2016-12-15
HeatLux Pro II (K152087)Home Skinovations , Ltd.2016-07-29
Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 (K161198)Usa Laser Biotech, Inc.2016-07-26
The Time Machine Series Lasers (K152461)Medical Lasers Manufacturer, Inc.2016-07-08
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 (K160947)Usa Laser Biotech, Inc.2016-07-05
LightStim Professional LED Bed (K153399)Led Intellectual Properties, LLC2016-07-05
Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom) (K153389)In Light Wellness Systems, Inc.2016-03-30
BioPhotas Celluma3 (K152280)Biophotas, Inc.2016-03-02
Varaya Sport (K150716)Varaya Photoceuticals, LLC2015-12-08
NuBrilliance Light Pain Therapy (K150554)Wellquest International, Inc.2015-10-06
Phoenix Thera-Lase System (K151521)Phoenix Thera-Lase Systems, LLC2015-09-04
LightStim for Pain LED Belt (K151333)Led Intellectual Properties, LLC2015-08-21
ZX2 Laser System (K150466)Lzr7, Inc.2015-06-08
HeatLux Pro I (K150175)Home Skinovations , Ltd.2015-03-31
QK-SYSTEMIC THERAPEUTIC APPARATUS (K141892)Harbin Quanke Medi-Technical Development Co., Ltd.2015-01-28
NEUROLUMEN PN-1000 (K142025)Neurolumen, LLC2015-01-21
3B Laser 500, 3B Laser 200, LA-X P 500, LA-X P 200 (K142722)Livetec GmbH2015-01-13
Applied BioPhotonics Phototherapy System ABPT1003 (K142256)Applied Biophotonics , Ltd.2015-01-07
HILTHERA 4.0 (K141861)Jeisys Medical, Inc.2015-01-07
Infrared Therapy System (K142340)Beijing Huatai Healthcare Technology Co., Ltd.2014-12-02
Power Twin21-50/Power Twin21-100 (K142215)Livetec GmbH2014-11-07
VELASII THERAPY LASER SYSTEM (K142078)Aspen Laser Systems, LLC2014-10-30
OPTON PRO (K141564)Zimmer Medizinsystems GmbH2014-10-24
INFRARED HEATING DEVICE (K140865)Pro Medical Supplies, Inc.2014-09-03
PHYSIOLASER OLYMPIC, SINGLE PROBES CW, CLUSTER PROBES CW, LIGHT NEEDLE, PHOTONIC SATELLITE (K131080)Reimers and Janssen GmbH2014-06-13
LUMIX 3 PLUS AND LUMIX 3 ULTRA SYSTEM (K132016)Texas Applied Biomedical Services, Inc.2014-06-02
GALLIEON-1 MEDICAL LASER (K132529)Future Device and Technology, Inc.2014-05-12
GIGALASER (K134017)Powermedic Aps2014-05-02
BIOPHOTAS CELLUMA (K131113)Biophotas, Inc.2014-01-15
CL10009 IR LASER (K130168)Curae'Lase, Inc.2014-01-10
LASER-STIM (K131259)Shenzhen Dongdixin Technology Co., Ltd.2013-12-27
AVANT LASER (K123474)Avant Wellness Systems, LLC2013-12-03
BIOLIGHT BIODYNAM (K130866)Biolight AB2013-10-25
3B LASER NEEDLE (K131797)Livetec GmbH2013-10-10
STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM (K123177)Laserstim, Inc.2013-07-03
CYNOSURE 1064NM DIODE LASER (K123971)Cynosure, Inc.2013-05-02
TENDER TOUCH (K121401)Sometech Corporation2013-05-01
ASA LASER SH1 (K122125)El.En Electronic Engineering Spa2013-01-25
BIOPHOTAS LIFELIGHT (K122237)Biophotas, Inc.2013-01-03
DIOWAVE LOW LEVEL COLD LASER SYSTEM (K121363)Technological Medical Advancments, Inc. (Tma)2012-11-23
CS1000 LIGHT THERAPY DEVICE (K110558)Genesis Health Light Corporation2012-07-12
HEATLUX (K120582)Home Skinovations , Ltd.2012-07-06
HEALITE II SYSTEM (K113668)Lutronic Corporation2012-06-19
LITECURE THERAPY COMPACT (K121487)Litecure, LLC2012-06-12
K-LASER (K120604)Eltech S.R.L2012-05-25
VARAYA AR , VARAYA SPORT (K112494)Varaya Photoceuticals, LLC2012-05-16
THERASAGE HEATING PAD (K120254)Therasage Corporation2012-03-06
WARP10,WARP75 (K113231)Quantum Devices, Inc.2012-02-27
L-SER KO LAMP (K112016)Ya-Man, Ltd.2012-02-10
DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBE (K113250)Dynatronics Corp.2012-02-09
ASA 'MPHI FAMILY DIODE LASER (K111901)Cynosure, Inc.2011-11-09
YOLO CURVE (K110342)Yolo Medical, Inc.2011-08-22
GAUNYING INFRARED LAMP (K110721)Foshan Gaunying Electronics Co., Ltd.2011-03-30
LUCIA (K102375)Meridian Co., Ltd.2011-02-25
NEXUS BIOWAVE 7W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 10W LITE IR LAMP SYSTEM, NEXUS BIOWAVE 30W PRO IR LAMP SYSTEM, NEXUS (K101893)Usa Laser Biotech, Inc.2011-02-17
LITECURE THERAPY SYSTEM (K103511)Litecure, LLC2011-01-25
HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT (K101894)Bioremedi Therapeutic Systems, Inc.2011-01-21
HVR PAIN RELIEF DEVICE (K101716)H.V.R., Inc.2011-01-11
GAUNYING INFRARED LAMP MODEL IL50 (K101693)Foshan Gaunying Electronics Co., Ltd.2011-01-05
MODEL LA-1200 MULTI-CHANNEL LASER THERAPY SYSTEM (K102134)United Integrated Services Co., Ltd.2010-12-23
PREMIO 10 MOXA (K101267)Sedatelec2010-12-03
LUMANOSITY CELEBRITY, MODEL 204 (K100213)Lumanosity, Inc.2010-10-04
INNOVATIVE MED MULTI WAVE LIGHT THERAPY SYSTEM (K093204)Innovative Med, Inc.2010-08-23
GAUNYING INFRARED LAMP (K102149)Foshan Gaunying Electronics Co., Ltd.2010-08-13
BACK-TEK (K101227)York Biomedical, Inc.2010-06-23
ELECTRO-LIGHT THERAPY (K090250)Hill Laboratories Co.2010-02-11
THERMOTEX PLATINUM SYSTEM (K092589)Eas Consulting Group, LLC2010-01-28
LASERPEN PRACTISE AND EXPERT, HANDYLASER SPRINT, HANDYLASER TRION, PHYSIOLASER OLYMPIC, POLYLASER (K091675)Reimers and Janssen GmbH2009-12-15
NEXUS XPULSE 805 IR LAMP SYSTEM, NEXUS XPULSE 980 IR LAMP SYSTEM, MODEL 805, 980 (K091726)Usa Laser Biotech, Inc.2009-10-28
TANDA RESTORE, MODEL PTSCS (K090008)Pharos Life Corporation2009-10-15
THERMAPULSE (K092222)Palomar Medical Products, Inc.2009-08-20
K-LASER K-1200, MODEL 12 W (K091497)Eltech S.R.L2009-08-19
SCALAR WAVE LASER SYSTEM (K091158)Stellar Lasers2009-08-10
AL T LASER, MODEL AVI HPLL-12 (K091285)Avicenna Laser Technology, Inc.2009-07-28
AKLARUS PHOTOTHERAPY SYSTEM (K083183)Hill Laboratories Co.2009-07-16
ANTI-WRINKLE LIGHT, MODEL 1302 AND PAIN THERAPY LIGHT, MODEL 1301 (K083580)Led Intellectual Properties, LLC2009-06-22
PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS (K081720)Prime Herbs Corporation2009-06-16
MULTI-CHANNEL LASER THERAPY SYSTEM (K082686)United Integrated Services Co., Ltd.2009-05-11
NEUTROLUMENPN SYSTEM, MODEL 1000 (K082223)Neurolumen, LLC2009-04-21
EZLASE (K083595)Biolase Technology, Inc.2009-04-14
LAPEX BCS (K081962)Meridian Co., Ltd.2008-12-29
BIOFLEX LD-R100 TREATMENT HEAD (K081355)Meditech International, Inc.2008-12-18
EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X (K083560)Lighthouse Technical Innovations, Inc.2008-12-11
NANOBEAM 940, MODEL 940-900-02 (K073681)Davaray, Inc.2008-12-09
THERAGEM PROFESSIONAL T1002 (K081505)Medica Health, Ltd.2008-11-19
DPL THERAPY SYSTEM (K081570)Led Technologies, LLC2008-11-07
LUMINEX INFRARED LAMP SYSTEM (K082969)Medical Laser Systems, Inc.2008-10-23
ML830TP (K080786)Microlight Corporation of America2008-10-03
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