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Hand-held IPL device (IPL Home Use Hair Removal Device)

Shenzhen IONKA Medical Technology Co., Ltd. · Model FZ-200 · UDI-DI 06973071102000

OHT
1
510(k) clearances
32
Adverse events (1 deaths)
0
Recalls
92
Facilities

Description

IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

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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.