Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart F — Physical Medicine Therapeutic Devices](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices) → [21 CFR 890.5500](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5500) → ILY — Lamp, Infrared, Therapeutic Heating # ILY · Lamp, Infrared, Therapeutic Heating _Physical Medicine · 21 CFR 890.5500 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILY ## Overview - **Product Code:** ILY - **Device Name:** Lamp, Infrared, Therapeutic Heating - **Regulation:** [21 CFR 890.5500](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5500) - **Device Class:** 2 - **Review Panel:** [Physical Medicine](/submissions/PM) ## Identification An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating. ## Classification Rationale Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9. ## Special Controls *Classification.* Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9. ## Recent Cleared Devices (20 of 229) Showing 20 most recent of 229 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253965](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILY/K253965.md) | 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. | Mar 19, 2026 | SESE | | [K242755](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILY/K242755.md) | Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) | Gigaalaser Company , Ltd. | May 19, 2025 | SESE | | [K231997](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILY/K231997.md) | SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) | Cure Point Therapeutics, Inc. | Oct 15, 2024 | SESE | | [K223642](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILY/K223642.md) | LED Lip Perfector, model: ZC-05 | Light Tree Ventures Europe B.V. | Mar 9, 2023 | SESE | | [K221189](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILY/K221189.md) | OLIZ LTB-1000A | Ltbio Co., Ltd. | Aug 29, 2022 | SESE | | [K213524](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILY/K213524.md) | CytonPro-5000 | Cytonsys, Inc. | Aug 10, 2022 | SESE | | [K202028](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILY/K202028.md) | dermalux Flex MD | Aesthetic Technology, Ltd. | Dec 16, 2020 | SESE | | [K171087](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILY/K171087.md) | AXON IR Heat Lamp | Crystal Medtech, LLC | Jul 7, 2017 | SESE | | [K163079](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILY/K163079.md) | HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System | Healthlight, LLC | Jun 13, 2017 | SESE | | [K170068](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILY/K170068.md) | Softcure 96 | Wellray Medical Laser, Inc. | May 5, 2017 | SESE | | [K162590](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILY/K162590.md) | Bashan TDP Heat Lamp | Chogqing Yuhe Medical Instruments Co., Ltd. | Feb 14, 2017 | SESE | | [K162763](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILY/K162763.md) | Vevazz LED Heat Lamp | Vevazz, LLC | Jan 5, 2017 | SESE | | [K160849](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILY/K160849.md) | WS(TM) Far-Infrared Therapy Unit, Model KP-B210 | Ws Far IR Medical Technology Co., Ltd. | Dec 15, 2016 | SESE | | [K152087](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILY/K152087.md) | HeatLux Pro II | Home Skinovations , Ltd. | Jul 29, 2016 | SESE | | [K161198](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILY/K161198.md) | Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 | Usa Laser Biotech, Inc. | Jul 26, 2016 | SESE | | [K152461](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILY/K152461.md) | The Time Machine Series Lasers | Medical Lasers Manufacturer, Inc. | Jul 8, 2016 | SESE | | [K160947](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILY/K160947.md) | 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. | Jul 5, 2016 | SESE | | [K153399](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILY/K153399.md) | LightStim Professional LED Bed | Led Intellectual Properties, LLC | Jul 5, 2016 | SESE | | [K153389](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILY/K153389.md) | Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom) | In Light Wellness Systems, Inc. | Mar 30, 2016 | SESE | | [K152280](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILY/K152280.md) | BioPhotas Celluma3 | Biophotas, Inc. | Mar 2, 2016 | SESE | ## Top Applicants - Usa Laser Biotech, Inc. — 6 clearances - Cynosure, Inc. — 4 clearances - Dynatronics Corp. — 4 clearances - Escada International, Inc. — 4 clearances - Meditech International, Inc. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILY](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILY) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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