ILY · Lamp, Infrared, Therapeutic Heating
Physical Medicine · 21 CFR 890.5500 · Class 2
Overview
| Product Code | ILY |
|---|---|
| Device Name | Lamp, Infrared, Therapeutic Heating |
| Regulation | 21 CFR 890.5500 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
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 | 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 | 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 | SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) | Cure Point Therapeutics, Inc. | Oct 15, 2024 | SESE |
| K223642 | LED Lip Perfector, model: ZC-05 | Light Tree Ventures Europe B.V. | Mar 9, 2023 | SESE |
| K221189 | OLIZ LTB-1000A | Ltbio Co., Ltd. | Aug 29, 2022 | SESE |
| K213524 | CytonPro-5000 | Cytonsys, Inc. | Aug 10, 2022 | SESE |
| K202028 | dermalux Flex MD | Aesthetic Technology, Ltd. | Dec 16, 2020 | SESE |
| K171087 | AXON IR Heat Lamp | Crystal Medtech, LLC | Jul 7, 2017 | SESE |
| K163079 | HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System | Healthlight, LLC | Jun 13, 2017 | SESE |
| K170068 | Softcure 96 | Wellray Medical Laser, Inc. | May 5, 2017 | SESE |
| K162590 | Bashan TDP Heat Lamp | Chogqing Yuhe Medical Instruments Co., Ltd. | Feb 14, 2017 | SESE |
| K162763 | Vevazz LED Heat Lamp | Vevazz, LLC | Jan 5, 2017 | SESE |
| K160849 | WS(TM) Far-Infrared Therapy Unit, Model KP-B210 | Ws Far IR Medical Technology Co., Ltd. | Dec 15, 2016 | SESE |
| K152087 | HeatLux Pro II | Home Skinovations , Ltd. | Jul 29, 2016 | SESE |
| K161198 | Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 | Usa Laser Biotech, Inc. | Jul 26, 2016 | SESE |
| K152461 | The Time Machine Series Lasers | Medical Lasers Manufacturer, Inc. | Jul 8, 2016 | SESE |
| 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. | Jul 5, 2016 | SESE |
| K153399 | LightStim Professional LED Bed | Led Intellectual Properties, LLC | Jul 5, 2016 | SESE |
| K153389 | Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom) | In Light Wellness Systems, Inc. | Mar 30, 2016 | SESE |
| K152280 | 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
