Panels › Physical Medicine › Product code ILY · Class 2
Lamp, Infrared, Therapeutic Heating
Regulation 890.5500
1510(k)s in 12 months (229 all time)
2recalls in 12 months (20 all time)
9recalls that name a 510(k)
Top companies in ILY
| Company | 510(k)s | Recalls |
|---|---|---|
| THOR Photomedicine Ltd | 0 | 9 |
| Usa Laser Biotech, Inc. | 6 | 0 |
| Cynosure, Inc. | 4 | 0 |
| Dynatronics Corp. | 4 | 0 |
| Escada International, Inc. | 4 | 0 |
| Meditech International, Inc. | 4 | 0 |
| Medx Electronics, Inc. | 4 | 0 |
| Biocare Systems, Inc. | 2 | 1 |
| Biophotas, Inc. | 3 | 0 |
| Bioscan, Inc. | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 19, 2026 | K253965 | CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLigh Wuhan PHOMED Technology Company , Ltd., CN | ILY |
| May 19, 2025 | K242755 | Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) Gigaalaser Company , Ltd., CN | ILY |
| Oct 15, 2024 | K231997 | SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) Cure Point Therapeutics, Inc. | ILY |
| Mar 9, 2023 | K223642 | LED Lip Perfector, model: ZC-05 Light Tree Ventures Europe B.V., NL | ILY |
| Aug 29, 2022 | K221189 | OLIZ LTB-1000A Ltbio Co., Ltd., KR | ILY |
| Aug 10, 2022 | K213524 | CytonPro-5000 Cytonsys, Inc. | ILY |
| Dec 16, 2020 | K202028 | dermalux Flex MD Aesthetic Technology, Ltd., GB | ILY |
| Jul 7, 2017 | K171087 | AXON IR Heat Lamp Crystal Medtech, LLC | ILY |
| Jun 13, 2017 | K163079 | HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System Healthlight, LLC | ILY |
| May 5, 2017 | K170068 | Softcure 96 Wellray Medical Laser, Inc. | ILY |
| Feb 14, 2017 | K162590 | Bashan TDP Heat Lamp Chogqing Yuhe Medical Instruments Co., Ltd., CN | ILY |
| Jan 5, 2017 | K162763 | Vevazz LED Heat Lamp Vevazz, LLC | ILY |
| Dec 15, 2016 | K160849 | WS(TM) Far-Infrared Therapy Unit, Model KP-B210 Ws Far IR Medical Technology Co., Ltd., TW | ILY |
| Jul 29, 2016 | K152087 | HeatLux Pro II Home Skinovations , Ltd., IL | ILY |
| Jul 26, 2016 | K161198 | Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 Usa Laser Biotech, Inc. | ILY |
| Jul 8, 2016 | K152461 | The Time Machine Series Lasers Medical Lasers Manufacturer, Inc. | ILY |
| Jul 5, 2016 | K160947 | 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 Usa Laser Biotech, Inc. | ILY |
| Jul 5, 2016 | K153399 | LightStim Professional LED Bed Led Intellectual Properties, LLC | ILY |
| Mar 30, 2016 | K153389 | Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom) In Light Wellness Systems, Inc. | ILY |
| Mar 2, 2016 | K152280 | BioPhotas Celluma3 Biophotas, Inc. | ILY |
| Dec 8, 2015 | K150716 | Varaya Sport Varaya Photoceuticals, LLC | ILY |
| Oct 6, 2015 | K150554 | NuBrilliance Light Pain Therapy Wellquest International, Inc. | ILY |
| Sep 4, 2015 | K151521 | Phoenix Thera-Lase System Phoenix Thera-Lase Systems, LLC | ILY |
| Aug 21, 2015 | K151333 | LightStim for Pain LED Belt Led Intellectual Properties, LLC | ILY |
| Jun 8, 2015 | K150466 | ZX2 Laser System Lzr7, Inc. | ILY |
| Mar 31, 2015 | K150175 | HeatLux Pro I Home Skinovations , Ltd., IL | ILY |
| Jan 28, 2015 | K141892 | QK-SYSTEMIC THERAPEUTIC APPARATUS Harbin Quanke Medi-Technical Development Co., Ltd., CN | ILY |
| Jan 21, 2015 | K142025 | NEUROLUMEN PN-1000 Neurolumen, LLC | ILY |
| Jan 13, 2015 | K142722 | 3B Laser 500, 3B Laser 200, LA-X P 500, LA-X P 200 Livetec GmbH, DE | ILY |
| Jan 7, 2015 | K142256 | Applied BioPhotonics Phototherapy System ABPT1003 Applied Biophotonics , Ltd., CN | ILY |
| Jan 7, 2015 | K141861 | HILTHERA 4.0 Jeisys Medical, Inc. | ILY |
| Dec 2, 2014 | K142340 | Infrared Therapy System Beijing Huatai Healthcare Technology Co., Ltd., CN | ILY |
| Nov 7, 2014 | K142215 | Power Twin21-50/Power Twin21-100 Livetec GmbH, DE | ILY |
| Oct 30, 2014 | K142078 | VELASII THERAPY LASER SYSTEM Aspen Laser Systems, LLC | ILY |
| Oct 24, 2014 | K141564 | OPTON PRO Zimmer Medizinsystems GmbH, DE | ILY |
| Sep 3, 2014 | K140865 | INFRARED HEATING DEVICE Pro Medical Supplies, Inc., CN | ILY |
| Jun 13, 2014 | K131080 | PHYSIOLASER OLYMPIC, SINGLE PROBES CW, CLUSTER PROBES CW, LIGHT NEEDLE, PHOTONIC SATELLITE Reimers and Janssen GmbH, DE | ILY |
| Jun 2, 2014 | K132016 | LUMIX 3 PLUS AND LUMIX 3 ULTRA SYSTEM Texas Applied Biomedical Services, Inc. | ILY |
| May 12, 2014 | K132529 | GALLIEON-1 MEDICAL LASER Future Device and Technology, Inc. | ILY |
| May 2, 2014 | K134017 | GIGALASER Powermedic Aps | ILY |
| Jan 15, 2014 | K131113 | BIOPHOTAS CELLUMA Biophotas, Inc. | ILY |
| Jan 10, 2014 | K130168 | CL10009 IR LASER Curae'Lase, Inc. | ILY |
| Dec 27, 2013 | K131259 | LASER-STIM Shenzhen Dongdixin Technology Co., Ltd., CN | ILY |
| Dec 3, 2013 | K123474 | AVANT LASER Avant Wellness Systems, LLC | ILY |
| Oct 25, 2013 | K130866 | BIOLIGHT BIODYNAM Biolight AB, SE | ILY |
| Oct 10, 2013 | K131797 | 3B LASER NEEDLE Livetec GmbH | ILY |
| Jul 3, 2013 | K123177 | STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM Laserstim, Inc. | ILY |
| May 2, 2013 | K123971 | CYNOSURE 1064NM DIODE LASER Cynosure, Inc. | ILY |
| May 1, 2013 | K121401 | TENDER TOUCH Sometech Corporation | ILY |
| Jan 25, 2013 | K122125 | ASA LASER SH1 El.En Electronic Engineering Spa, IT | ILY |
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