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Forma
FORMATK SYSTEMS LTD · Model FS10000 · UDI-DI 07290016681000
1
510(k) clearances
63
Adverse events
1
Recalls
74
Facilities
Description
Multi-modality system supporting IPL (Intense Pulsed Light), RF (Radio Frequency) and Diamond Peeling applicators for various treatments such as Hair Removal, Acne, Pigmented Lesions, Skin Dermabrasion
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-07-13 | Bios S.r.l. | In some systems, the unit continues to emit RF energy after the PAUSE button is pressed. |
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Get your free API keyRead the docsData 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.