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510(k) Data Aggregation
K Number
K183708Device Name
Poly Clear
Manufacturer
Medtek Skincare, LLC
Date Cleared
2019-09-17
(260 days)
Product Code
OLP
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Medtek Skincare, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Poly Clear combination of Red (633nm=10mm) and Blue (417nm=10mm) is intended to emit energy in the red, blue regions of the light spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.
Device Description
The Poly Clear is a portable device that has three separate detachable treatment heads, each containing a total of 1,820 LEDs in the treatment head. The treatment head is attached to a lifting stand that is attached to the main frame on a rolling stand. The user interface for applying treatment is a key lock to power ON/Off the device and a display screen attached to the main frame that runs the software (password protected-lockout code, runs treatment time/ treatment heads) for the device. 6 pairs of protective eyewear are included with the device.
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K Number
K180875Device Name
POLY REJUV
Manufacturer
Medtek Skincare, LLC
Date Cleared
2018-09-14
(164 days)
Product Code
OHS
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Medtek Skincare, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Poly Rejuv Model 633 is intended to emit energy in the red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
Device Description
The Poly Rejuv is a portable device that has a detachable treatment head, containing a total of 1,820 red LEDs in the treatment head. The treatment head is attached to a lifting stand that is attached to the main frame on a rolling stand. The user interface for applying treatment is a key lock to power ON/Off the device and a display screen attached to the main frame that runs the software (password protected-lockout code, runs treatment time/ treatment head) for the device. 12 pairs of protective eyewear are included with the device. The device is sold as Over the Counter (OTC) to commercial establishments only and not for home use. The Poly Rejuv is not intended to be used by laypersons. Poly Rejuv is intended to only be operated by a person who has been trained by the Sponsor according to their Customer Training Plan.
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