ST-302 INFRAREX— 510(k) K990233

Substantially Equivalent

Skylark Device Co., Ltd.

FDA 510(k) clearance K990233 for ST-302 INFRAREX, Substantially Equivalent on 1999-10-27. Applicant: Skylark Device Co., Ltd..

Clearance details

Applicant: Skylark Device Co., Ltd.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 1999-01-25
Decision date: 1999-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

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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.