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EnergyLounger

Shenzhen Kaiyan Medical Equipment Co,. Ltd · Model TY-01 · UDI-DI 06970006971212

OHS OLI ILY

510(k) clearances

107

Adverse events

Recalls

131

Facilities

Description

Mi is used to reduce the circumference of the hips, waist and thighs and is indicated for use as a non. invasive dermatological. M2 is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment offull-face wrinkles. M3 is intended to emit energy in the visible and IR spectrum intended to provide topical heating for thepurpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness.minor arthritis, pain or muscle spasm, the temporary increase in local blood circulation, and the temporaryrelaxation of muscles.

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.