Lamp, Infrared, Therapeutic Heating
Physical Medicine · 21 CFR 890.5500
Recent MDR events
291 adverse event reports on file
- NEURONIC LIGHTJul 27, 2026MalfunctionShenzhen Kaiyan Medical Equipment Co., Ltd3011644607-2026-00002
- NEURONIC LIGHTJun 10, 2026MalfunctionShenzhen Kaiyan Medical Equipment Co., Ltd.MW5189209
- LIGHTFORCEMay 6, 2026InjuryLitecure, Llc A Djo Llc Company9616086-2026-00016
- LIGHTFORCEApr 29, 2026InjuryLitecure, Llc A Djo Llc Company9616086-2026-00011
- LIGHTFORCEApr 29, 2026InjuryLitecure, Llc A Djo Llc Company9616086-2026-00012
- LIGHTFORCEApr 29, 2026InjuryLitecure, Llc A Djo Llc Company9616086-2026-00014
- LIGHTFORCEApr 29, 2026InjuryLitecure, Llc A Djo Llc Company9616086-2026-00010
- PLATINUMLED BIOMAX 900Apr 27, 2026InjuryPlatinum Led Holdings Llc.MW5187254
- RED LIGHT MASKApr 16, 2026InjuryHigher Dose Llc.MW5186922
- COMPANIONMar 18, 2026InjuryLitecure, Llc9616086-2026-00007
Event type breakdown
Recalls
20 recall events for this product code
- MITO RED LIGHT INCOpen, ClassifiedJun 17, 2026
Mito Red Light, Super Mobile
The near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or burst into flames.
Z-2478-2026 · View FDA record ↗ - Technological Medical Advancements LLCOpen, ClassifiedMay 11, 2026
Diowave Laser System, REF: Diowave 250W
Software update is needed for laser systems, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms, stiffness associated with minor arthritis, and to temporarily increase local blood circulation, operating at a maximum average power output of 70W, which is beyond the FDA cleared 60W.
Z-2162-2026 · View FDA record ↗ - THOR Photomedicine LtdOpen, ClassifiedAug 22, 2025
Brand Name: THOR
The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
Z-2416-2025 · View FDA record ↗ - THOR Photomedicine LtdOpen, ClassifiedAug 22, 2025
Brand Name: THOR
The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
Z-2417-2025 · View FDA record ↗ - THOR Photomedicine LtdOpen, ClassifiedAug 22, 2025
Brand Name: THOR
The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
Z-2418-2025 · View FDA record ↗ - THOR Photomedicine LtdOpen, ClassifiedAug 22, 2025
Brand Name: THOR
The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
Z-2419-2025 · View FDA record ↗ - THOR Photomedicine LtdOpen, ClassifiedFeb 1, 2024
NovoTHOR Whole Body Light Pod, Gen 3.0
One of the ball studs attaching a gas strut to the canopy may fail. There is potential risk of injury should a ball stud fail when someone is in the NovoTHOR and trying to open or close the canopy
Z-0972-2024 · View FDA record ↗ - Thor Photomedicine LtdOpen, ClassifiedDec 1, 2023
NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176
Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.
Z-0453-2024 · View FDA record ↗ - Thor Photomedicine LtdOpen, ClassifiedDec 1, 2023
G041 POD, THOR NOVO GEN 2.0 XL whole body red light therapy bed, model S1177
Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.
Z-0454-2024 · View FDA record ↗ - Thor Photomedicine LtdOpen, ClassifiedDec 1, 2023
NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183
Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift.
Z-0455-2024 · View FDA record ↗
Registered firms
606 firms currently registered for this product code
Alma Lasers Ltd.
CAESAREA Northern, IL
Ningbo Jinhui Photoelectricity Technology Co., Ltd
Yuyao City, Ningbo City, Zhejiang Province, CN
Shenzhen Yihong Lighting Co., Ltd.
Shenzhen Guangdong, CN
Shenzhen Qianhai Nicemay Medical Beauty Instruments Co., Ltd.
Shenzhen Guangdong, CN
Asclepius Medical Holdings Llc
Wheat Ridge, CO, US
Spectra Therapy Llc
Port Huron, MI, US
Shenzhen Sinoco Medical Equipment Co.,ltd.
Shenzhen Guangdong, CN
Grahope New Materials Technologies Inc.
Shenzhen Guangdong, CN
Photon Ink, Llc
Rancho Cordova, CA, US
Silhouet-tone Corporation
LAVAL Quebec, CA
Laser Biotech International
North Chesterfield, VA, US
Ipg Medical Corporation
Marlborough, MA, US
Laser Marketing Group, Llc
Lehi, UT, US
Shanghai Foreign Trade Enterprises Pudong Co., Ltd.
Shanghai, CN
Guangzhou Ahead Intelligent Technology Co., Ltd.
Guangzhou Guangdong, CN
E.shine Systems Limited
Shenzhen Guangdong, CN
Zimmer Medizinsysteme Gmbh
NEU-ULM Bavaria, DE
Fringe, Inc.
Lakewood, CO, US
Shenzhen Borria Technology Co.,ltd
Shenzhen Guangdong, CN
Cynosure Lutronic Technology Corporation
Goyang Gyeonggi, KR
Microlight Corporation Of America
Missouri City, TX, US
Lumara Systems
San Jose, CA, US
Kerber Usa Inc.
Amherst, NY, US
510(k) clearances
229 clearances for this product code
- Wuhan PHOMED Technology Company , Ltd.Mar 19, 2026
K253965 · CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)
- Gigaalaser Company , Ltd.May 19, 2025
K242755 · Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)
- Cure Point Therapeutics, Inc.Oct 15, 2024
K231997 · SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)
- Light Tree Ventures Europe B.V.Mar 9, 2023
K223642 · LED Lip Perfector, model: ZC-05
- Ltbio Co., Ltd.Aug 29, 2022
K221189 · OLIZ LTB-1000A
- Cytonsys, Inc.Aug 10, 2022
K213524 · CytonPro-5000
- Aesthetic Technology, Ltd.Dec 16, 2020
K202028 · dermalux Flex MD
- Crystal Medtech, LLCJul 7, 2017
K171087 · AXON IR Heat Lamp