INFRALUX HEAT LAMP— 510(k) K864714

Substantially Equivalent for Some Indications

Infralux International, Inc.

FDA 510(k) clearance K864714 for INFRALUX HEAT LAMP, Substantially Equivalent for Some Indications on 1987-03-12. Applicant: Infralux International, Inc..

Clearance details

Applicant: Infralux International, Inc.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 1986-12-03
Decision date: 1987-03-12
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Fairfield, NJ, US

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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.