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510(k) Data Aggregation
K Number
K220064Device Name
Synergy Marble (Model: Opasm)
Manufacturer
Date Cleared
2022-07-22
(193 days)
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
YRS Group Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SYNERGY MARBLE is a hand-held device for over-the counter aesthetic purposes. The device red light and amber light are intended for the use in treating wrinkles on the face, and the blue light is intended for the treatment of the mild to moderate inflammatory acne.
Device Description
The SYNERGY MARBLE is an over-the-counter, battery powered hand-held light emitting diode (LED) device that emits light energy in the red, blue and amber spectrum for the treatment of wrinkles or mild to moderate inflammatory acne on the face. The SYNERGY MARBLE components include an applicator, a charging station and an adaptor. The treatment surface is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user repairable components. The device is sold as Over the Counter (OTC).
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K Number
K210954Device Name
Synergy
Manufacturer
Date Cleared
2021-06-29
(91 days)
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
YRS Group Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SYNERGY is an Over-the-Counter (OTC) device intended for the use in treating wrinkles on the face.
Device Description
The SYNERGY is an over-the-counter, battery powered, hand-held light emitting diode (LED) device that emits light energy in the red and infrared spectrum for the treatment of wrinkles on the face. The SYNERGY components include an applicator, a charging station and an adaptor. The treatment surface is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user repairable components. The device is sold for Over the Counter (OTC) use.
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