DeviceClearance

Product code ILY— Physical Medicine

GAUNYING INFRARED LAMP

Classification name
Lamp, Infrared, Therapeutic Heating
Device class
Class 2
Regulation
21 CFR 890.5500
Advisory panel
Physical Medicine
Total cleared
229
First cleared
Most recent

Market context for product code ILY

FDA has cleared 229 devices under product code ILY between 1985 and 2026, filed by 167 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code ILY

Adverse events under product code ILY

product code ILY
Death
3
Total
3

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code ILY

1–100 of 229

Data sourced from openFDA. This site is unofficial and independent of the FDA.