ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT— 510(k) K060191

Substantially Equivalent

Accelerated Care Plus Corp.

FDA 510(k) clearance K060191 for ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT, Substantially Equivalent on 2006-07-12. Applicant: Accelerated Care Plus Corp..

Clearance details

Applicant: Accelerated Care Plus Corp.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2006-01-25
Decision date: 2006-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reno, NV, 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.