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Dreame

Shenzhen Rainbow Technology Co.,Ltd · Model AB01P · UDI-DI 06978368600245

OHS OLP ILY

510(k) clearances

107

Adverse events

Recalls

134

Facilities

Description

*Red+Infrared light: Treatment of full-face wrinkles. *Red light: Treatment of full-face wrinkles. *Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm;relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. *Blue light: Treatment of mild to moderate inflammatory acne. *Red+Blue light: Treatment of mild to moderate inflammatory acne.

Recalls

Date	Firm	Reason
2018-06-29	Quasar Bio-Tech, Inc.	Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.
2018-06-29	Quasar Bio-Tech, Inc.	Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.
2018-06-29	Quasar Bio-Tech, Inc.	Quasar did not receive FDA clearance for claims of collagen/elastin production as stated on the packaging and in the user manuals.
2008-06-18	Sybaritic, Inc	Sybaritic stated that no 510(k) has been filed for the device (Lumi 8 Intense LED Light Facial System). No injuries or illness reported.

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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.