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Irradiation Aesthetic Device

Chongqing Peninsula Medical Technology Co., Ltd. · Model HairPro · UDI-DI 06971777450029

510(k) clearances

Adverse events

Recalls

Facilities

Description

Irradiation Aesthetic Device (Model: HairPro) consists of laser diodes that are spread throughout the cap. The device uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. In the process of the cap working, the indicator blinks red based on the working frequency of the laser diodes. Built-in timing function, the cap can record the time per treatment, and the cap can stop working automatically after ach 30 minutes treatment. When the built-in IR detected the cap is not worn on the head, the laser light output will be automatically suspended immediately and the cap will automatically shut down after 10 minutes.

Recalls

Date	Firm	Reason
2022-09-01	OMM Imports, Inc. dba Zero Gravity	The firm distributed the laser products without affixing the warning, aperture, certification, and identification labels. In addition, the firm failed to provide safety information

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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.