ACUBEAM, SUPER NOVA, DIO— 510(k) K022888

Substantially Equivalent

Light Force Therapy, Inc.

FDA 510(k) clearance K022888 for ACUBEAM, SUPER NOVA, DIO, Substantially Equivalent on 2002-12-11. Applicant: Light Force Therapy, Inc.. Device class: 2.

Clearance details

Applicant
Light Force Therapy, Inc.
Product code
Code ILY
Device class
Class 2
Regulation
21 CFR 890.5500
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Boulder, CO, US
Download summary PDFView on FDA.gov ↗

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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 →

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