Product code ILY
- Device name
- Lamp, Infrared, Therapeutic Heating
- Medical specialty
- Physical Medicine
- Device class
- 2
- Regulation number
- 890.5500
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253965 | CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.) | Wuhan PHOMED Technology Company , Ltd. | 2026-03-19 |
| K242755 | Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) | Gigaalaser Company , Ltd. | 2025-05-19 |
| K231997 | SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) | Cure Point Therapeutics, Inc. | 2024-10-15 |
| K223642 | LED Lip Perfector, model: ZC-05 | Light Tree Ventures Europe B.V. | 2023-03-09 |
| K221189 | OLIZ LTB-1000A | Ltbio Co., Ltd. | 2022-08-29 |
| K213524 | CytonPro-5000 | Cytonsys, Inc. | 2022-08-10 |
| K202028 | dermalux Flex MD | Aesthetic Technology, Ltd. | 2020-12-16 |
| K171087 | AXON IR Heat Lamp | Crystal Medtech, LLC | 2017-07-07 |
| K163079 | HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System | Healthlight, LLC | 2017-06-13 |
| K170068 | Softcure 96 | Wellray Medical Laser, Inc. | 2017-05-05 |
| K162590 | Bashan TDP Heat Lamp | Chogqing Yuhe Medical Instruments Co., Ltd. | 2017-02-14 |
| K162763 | Vevazz LED Heat Lamp | Vevazz, LLC | 2017-01-05 |
| K160849 | WS(TM) Far-Infrared Therapy Unit, Model KP-B210 | Ws Far IR Medical Technology Co., Ltd. | 2016-12-15 |
| K152087 | HeatLux Pro II | Home Skinovations , Ltd. | 2016-07-29 |
| K161198 | Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 | Usa Laser Biotech, Inc. | 2016-07-26 |
| K152461 | The Time Machine Series Lasers | Medical Lasers Manufacturer, Inc. | 2016-07-08 |
| K153399 | LightStim Professional LED Bed | Led Intellectual Properties, LLC | 2016-07-05 |
| 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 IR Lamp System | Usa Laser Biotech, Inc. | 2016-07-05 |
| K153389 | Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom) | In Light Wellness Systems, Inc. | 2016-03-30 |
| K152280 | BioPhotas Celluma3 | Biophotas, Inc. | 2016-03-02 |
| K150716 | Varaya Sport | Varaya Photoceuticals, LLC | 2015-12-08 |
| K150554 | NuBrilliance Light Pain Therapy | Wellquest International, Inc. | 2015-10-06 |
| K151521 | Phoenix Thera-Lase System | Phoenix Thera-Lase Systems, LLC | 2015-09-04 |
| K151333 | LightStim for Pain LED Belt | Led Intellectual Properties, LLC | 2015-08-21 |
| K150466 | ZX2 Laser System | Lzr7, Inc. | 2015-06-08 |
| K150175 | HeatLux Pro I | Home Skinovations , Ltd. | 2015-03-31 |
| K141892 | QK-SYSTEMIC THERAPEUTIC APPARATUS | Harbin Quanke Medi-Technical Development Co., Ltd. | 2015-01-28 |
| K142025 | NEUROLUMEN PN-1000 | Neurolumen, LLC | 2015-01-21 |
| K142722 | 3B Laser 500, 3B Laser 200, LA-X P 500, LA-X P 200 | Livetec GmbH | 2015-01-13 |
| K141861 | HILTHERA 4.0 | Jeisys Medical, Inc. | 2015-01-07 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00810140063113 | RENPHO | Joicom Corporation | 2026-07-24 |
| 00810140063120 | RENPHO | Joicom Corporation | 2026-07-24 |
| 00850083596002 | LaserWrap | SPECTRA THERAPY, LLC | 2026-07-24 |
| 00850083596026 | LaserWrap | SPECTRA THERAPY, LLC | 2026-07-24 |
| 00810140062833 | RENPHO | Joicom Corporation | 2026-07-24 |
| 00850026680218 | Aura Wellness | Aura Wellness, LLC | 2026-07-21 |
| 08800020111852 | HILTHERA | Jeisys Medical Inc. | 2026-07-21 |
| 00850087184038 | Homedics | FKA DISTRIBUTING CO., LLC | 2026-07-13 |
| 08800291820323 | HEALITE II | Cynosure Lutronic Technology Corporation | 2026-06-23 |
| B317KLGUHUF0 | GIRO | ELTECH KLASER SRL | 2026-05-27 |
| B317KLGEHUF0 | GIRO | ELTECH KLASER SRL | 2026-05-27 |
| B317KLGCHUF0 | GIRO | ELTECH KLASER SRL | 2026-05-27 |
| 00860179001013 | FUSION PBM Plus Light | Dentlight Inc. | 2026-05-27 |
| 00860009854598 | OvationULT | Body Balance System, LLC | 2025-10-30 |
| 00860009854536 | OvationULT | Body Balance System, LLC | 2024-06-21 |
| 00816073022623 | Wabbo Infrared Lamp | Health Body World Supply Inc. | 2023-10-16 |
| 00860009854529 | Ovation | Body Balance System, LLC | 2023-09-18 |
| 08800077100045 | SMARTLUX MINI | Medmix Co., Ltd. | 2022-07-25 |
| 00860925000338 | UltraSlim Digital | PHOTONICA USA, LLC | 2021-01-04 |
| 00816073022654 | XinFeng Heat Lamp | Health Body World Supply Inc. | 2019-07-12 |
| 00816073022647 | XinFeng Heat Lamp | Health Body World Supply Inc. | 2019-07-11 |
| 00816073022371 | XinFeng TDP Heat Lamp Head | Health Body World Supply Inc. | 2017-08-06 |
| 00816073022388 | XinFeng TDP Heat Lamp Head | Health Body World Supply Inc. | 2017-08-06 |
| 00816073020308 | XinFeng TDP Heat Lamp | Health Body World Supply Inc. | 2016-11-05 |
| 00816073020049 | XinFeng TDP Heat Lamp | Health Body World Supply Inc. | 2016-11-05 |
| 00816073020025 | XinFeng TDP Heat Lamp | Health Body World Supply Inc. | 2016-11-05 |
| 00816073020018 | TDP Heat Lamp | Health Body World Supply Inc. | 2016-11-05 |
| 00816073020001 | XinFeng TDP Heat Lamp | Health Body World Supply Inc. | 2016-11-05 |
| 00816073020070 | XinFeng TDP Heat Lamp | Health Body World Supply Inc. | 2016-11-04 |
| 00816073020032 | XinFeng TDP Heat Lamp | Health Body World Supply Inc. | 2016-11-04 |