BIOFLEX LD-R100 TREATMENT HEAD— 510(k) K081355

Substantially Equivalent

Meditech International, Inc.

FDA 510(k) clearance K081355 for BIOFLEX LD-R100 TREATMENT HEAD, Substantially Equivalent on 2008-12-18. Applicant: Meditech International, Inc..

Clearance details

Applicant: Meditech International, Inc.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2008-05-14
Decision date: 2008-12-18
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Toronto, Ontario, CA

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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.