S-530

FORMATK SYSTEMS LTD · Model FS90012 · UDI-DI 07290016681369

ONF Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

IPL (Intense Pulsed Light) Applicator to be used with Formatk Systems Ltd supporting systems for the treatment of Acne, Pigmented Lesions and Vascular lesions

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.