ILY — Lamp, Infrared, Therapeutic Heating Class II
FDA product code ILY covers "Lamp, Infrared, Therapeutic Heating", a Class II medical device regulated under 21 CFR 890.5500. Submissions are reviewed by the Physical Medicine panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ILY
- Device Class
- Class II
- Regulation Number
- 890.5500
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253965 | wuhan phomed technology company | CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; Cure | March 19, 2026 |
| K242755 | gigaalaser company | Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CH | May 19, 2025 |
| K231997 | cure point therapeutics | SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) | October 15, 2024 |
| K223642 | light tree ventures europe | LED Lip Perfector, model: ZC-05 | March 9, 2023 |
| K221189 | ltbio co | OLIZ LTB-1000A | August 29, 2022 |
| K213524 | cytonsys | CytonPro-5000 | August 10, 2022 |
| K202028 | aesthetic technology | dermalux Flex MD | December 16, 2020 |
| K171087 | crystal medtech | AXON IR Heat Lamp | July 7, 2017 |
| K163079 | healthlight | HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM ( | June 13, 2017 |
| K170068 | wellray medical laser | Softcure 96 | May 5, 2017 |
| K162590 | chogqing yuhe medical instruments co | Bashan TDP Heat Lamp | February 14, 2017 |
| K162763 | vevazz | Vevazz LED Heat Lamp | January 5, 2017 |
| K160849 | ws far ir medical technology co | WS(TM) Far-Infrared Therapy Unit, Model KP-B210 | December 15, 2016 |
| K152087 | home skinovations | HeatLux Pro II | July 29, 2016 |
| K161198 | usa laser biotech | Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 | July 26, 2016 |
| K152461 | medical lasers manufacturer | The Time Machine Series Lasers | July 8, 2016 |
| K153399 | led intellectual properties | LightStim Professional LED Bed | July 5, 2016 |
| K160947 | usa laser biotech | LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System | July 5, 2016 |
| K153389 | in light wellness systems | Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom) | March 30, 2016 |
| K152280 | biophotas | BioPhotas Celluma3 | March 2, 2016 |