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510(k) Data Aggregation
K Number
K222356Device Name
Claritag Advanced
Manufacturer
DGI Technologies
Date Cleared
2023-05-18
(287 days)
Product Code
GEH
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
DGI Technologies
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Claritag Advanced is intended for the OTC treatment of skin tags in adults age 21 years or older.
Device Description
The Claritag Advanced is a portable, hand operated device intended for use in the treatment of skin tag removal using a cryogen application system. The Claritag Kit contains the Claritag handheld device and the Claritag Base. The Claritag device houses the Claritag "squeeze and freeze" heads with foam treatment pads and liquid cooling gas. A spare set of treatment heads is included. The Claritag Base will activate the freezing once the heads are placed into the base. Pressing down on the base sends the liquid cooling gas to the Claritag "squeeze and freeze heads." Instructions for Use are included.
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K Number
K190747Device Name
Claritag
Manufacturer
DGI Technologies
Date Cleared
2019-10-31
(223 days)
Product Code
GEH, CLA
Regulation Number
878.4350Why did this record match?
Applicant Name (Manufacturer) :
DGI Technologies
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Claritag is indicated for use in the treatment of achrochordons (skin tags).
Device Description
The Claritag device is indicated for the treatment of skin tags. Claritag® is a portable, hand operated device intended for use in the treatment of skin tag removal using a cryogen application system. The cryogen application methodology for skin tag removal is a widely accepted practice used by physicians for decades.
The Claritag device is provided in a kit containing the main device (canister containing aerosolized cryogen, fitted with two treatment head activation base, 20 disposal single use foam pads, tweezers (which are provided as an optional accessory) and Instructions for Use.
The mechanism of action for cryotherapy are the direct effects of freezing on the cells, and the vascular stasis which develops in the tissue after thawing.
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