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SOLAWAVE

Shenzhen Kaiyan Medical Equipment Co,. Ltd · Model EY-20N · UDI-DI 00810137610429

OHS

510(k) clearances

107

Adverse events

Recalls

134

Facilities

Description

The LED Eye Mask, model: EY-20N is an over-the-counter light-emiting diode (LEDdevice that emits energy for dermatology to treat wrinkles within the periorbital region. The device usesfour types of LEDs is 605nm, 633nm, 660nm, 830nm. The LED Eye Mask components contain the mainunit, USB cable cord and velcro straps and removable eye protection. There is a total of 40 LEDs toprovide a power intensity of about 65 mW/cm?. The device has only one button to turn on/off.The user wears the device on their eye area for the treatment, and the device will shut down automatically

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.