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510(k) Data Aggregation
K Number
K201107Device Name
Opera Lebody (Gold), Opera Lebody (Zafiro)
Manufacturer
GTG Wellness Co., Ltd.
Date Cleared
2020-06-22
(59 days)
Product Code
OHS
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
GTG Wellness Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OPERA LEBODY is an over the counter device that is intended for the use in the treatment of full face wrinkles.
Device Description
The OPERA LEBODY is a device which allows emission of LED light in the red (630nm) and IR (830nm) spectrum onto the face, which induces photobiological effect to the face for reduction of wrinkle. OPERA LEBODY includes the mask that contains LEDs on the inner surface, the controller which turns on and off the device, a cradle that holds the face mask, a pouch that keeps the product, and USB cable that delivers electrical power to the controller for operation or for charging the battery contained in the controller.
The user wears a mask and operates OPERA LEBODY using the controller. The device will automatically turn off after 10 minutes. Emitted light from LEDs are not intended for ocular or ophthalmic treatment. To prevent irradiation of LED lights to eyes during the treatment, OPERA LEBODY has protective eye guide which blocks light energy from LEDs.
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