AXON IR Heat Lamp— 510(k) K171087

Substantially Equivalent

Crystal Medtech, LLC

FDA 510(k) clearance K171087 for AXON IR Heat Lamp, Substantially Equivalent on 2017-07-07. Applicant: Crystal Medtech, LLC.

Clearance details

Applicant: Crystal Medtech, LLC
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2017-04-12
Decision date: 2017-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schofield, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ILY

product code ILY

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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