ILY
- Product code
- ILY
- Device name
- Lamp, Infrared, Therapeutic Heating
- Device class
- Class 2
- 21 CFR
- 21 CFR 890.5500
- Medical specialty
- Physical Medicine
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 229 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253965 | 2026-03-19 | Wuhan PHOMED Technology Company , Ltd. | CureLight Medical Diode Laser Systems (CureLight F2-… | FDA |
| K242755 | 2025-05-19 | Gigaalaser Company , Ltd. | Medical Diode Laser Systems (VELAS II-30B, VELAS II-… | |
| K231997 | 2024-10-15 | Cure Point Therapeutics, Inc. | SIRONA 100 Therapy Laser System (OEM's Model EVANLAS… | — |
Official FDA classification page: ILY
Classification and pathway per current FDA publications. Data from openFDA (CC0).