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510(k) Data Aggregation
K Number
K202517Device Name
Cytrellis Dermal Micro-Coring System
Manufacturer
Cytrellis Biosystems, Inc.
Date Cleared
2021-07-09
(311 days)
Product Code
QAI
Regulation Number
878.4430Why did this record match?
Applicant Name (Manufacturer) :
Cytrellis Biosystems, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cytrellis® Dermal Micro-Coring™ System is intended for the treatment of moderate and severe wrinkles in the mid and lower face.
The Cytrellis Dermal Micro-Coring System is indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV.
Device Description
The Cytrellis Dermal Micro-Coring System removes unwanted skin by rapidly excising full thickness micro-columns of the dermal and epidermal tissue via specially designed hollow coring needles. The needles are controlled to precise coring depths and positions by the device console and handpiece. The system provides a range of skin removal percentages (treatment densities) and needle depths settings to customize the user needs that is controlled by the LCD touch display on the console. The treatment is applied in 1cm2 areas of the skin at a time by the handpiece, which has a vacuum assisted disposable in order to help with alignment between treatment areas. The Cytrellis Dermal Micro-Coring System mechanically removes full thickness sections of skin without evidence of scarring or need for surgical procedure. As much as 7.9% of the surface area of the skin is removed in columns that are the size of the inner diameter of the needle which is too small to cause visible scarring. The holes quickly close because of the natural elastin of the skin as they start to heal. This wound response, combined with the mechanical removal of the skin's surface area, leads to a reduction in the appearance of wrinkles.
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