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AROMA GRAND

Daeju Medi Tech Engineering · Model 1.0 · UDI-DI 08800017500126

OHT Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

The subject device, AROMA GRAND is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). It utilizes a semiconductor diode as a laser source (808nm). The laser power is delivered to the treatment area via a laser hand-piece.

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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.