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510(k) Data Aggregation
K Number
K132833Device Name
ULTRA RENEW PLUS
Manufacturer
ACCORD MEDIA
Date Cleared
2014-06-17
(280 days)
Product Code
OLP, ISA, OHS
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ACCORD MEDIA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Accord Media Ultra Renew Plus is intended to be used:
LED functional mode
- To emit energy in the red and blue region of the spectrum, specifically to treat mild to moderate acne on the face.
- To emit energy in the red region of the spectrum for the treatment of periorbital wrinkles.
Ultrasonic functional mode
- As an electrically powered device intended for medical purposes to relieve minor aches and pains.
Device Description
The Ultra Renew Plus is a hand held, mains powered, device used for the treatment of acne, periorbital wrinkles, and the relief of minor aches and pains. The Ultra Renew Plus combines two (2) functional modes of operation, LED and ultrasonic. The LED functional mode provides narrow bandwidth spectral output in the blue (415 ± 5 nm) and red (650 ± 5 nm) ranges. The ultrasonic functional mode operates at a fixed frequency of 3 MHz ± 5%. The Ultra Renew Plus uses a supplied power adaptor.
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