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510(k) Data Aggregation
K Number
K242796Device Name
CryoGlow (FW3XXXX)
Manufacturer
Date Cleared
2024-11-27
(72 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SharkNinja Operating, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CryoGlow LED mask emits energy in the red and infrared light spectrum for the lines and wrinkles and in the red, blue, and infrared light spectrum for the treatment of mild-to-moderate inflammatory acne.
Device Description
The CryoGlow mask is an over-the-counter (OTC) beauty device intended to emit energy in the red and infrared spectrum to treat fine lines and wrinkles, and in the red, blue, and infrared light spectrum to treat mild-to-moderate inflammatory acne. It is made of molded plastic and is designed to be worn over the face. The device incorporates 480 LEDs (160 tri-wick packages) that emit combinations of red, blue, and infrared light depending on the skin routine chosen. The mask also incorporates under-eye cooling technology. Using the attached remote controller and graphical user interface, users may choose from three skin care routines: Better Aging (red and infrared light), Skin Clearing (blue, red and infrared light), and Skin Sustain (blue and red light). During each routine, a combination of red, blue, and infrared light is emitted for a prescribed amount of time.
The CryoGlow mask also incorporates an under-eye cooling function. Peltiers and fans are used to cool the built-in chill pads (cool sinks) that rest on the surface of the skin under the eyes. The cooling feature turns on automatically with each skin routine, but users may turn off the undereye cooling function during a skin care routine or run a stand-alone under-eye cooling session. The cooling function is intended to refresh/invigorate/soothe the skin. Optional clip-on chill pads are provided with the device to help achieve the proper fit.
Silicone eye shields are built into the design of the mask to help protect the user's eyes from the LED light during a treatment routine. Other built-in safety features include an automatic shut off and auto-dimming feature where the LED lights dim when the mask is away from the user's face. Electrical, mechanical, optical, and thermal safety testing has been conducted to support the safety and effectiveness of the mask.
The CryoGlow mask must be charged prior to use and is provided with a USB-A to USB-C charging cord and USB-A charging block. An optional charging stand is provided separately.
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