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510(k) Data Aggregation
K Number
K172358Device Name
Instalief
Manufacturer
Privi Medical Pte Ltd
Date Cleared
2018-01-10
(160 days)
Product Code
LKX
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Privi Medical Pte Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Instalief is a single use device for the treatment of hemorrhoids by applying it directly to the swollen hemorrhoidal tissues. By applying cold to the tissue, the inflammation is reduced. The device can be used for the treatment of external hemorrhoids and internal hemorrhoids. The device is for adults only.
Device Description
Instalief™ is a device designed for the treatment of internal and external hemorrhoids by the application of cold directly to the swollen hemorrhoidal tissue. The device consists of an outer bag which houses an endothermic salt, a smaller water-containing frangible bag, an insertion tip with an attached compliant balloon, as well as a separate component that aids in the usage of the device, known as the squeezer. To use the device, the user first bursts the frangible bag by pressing on it, initiating an endothermic process between the water and endothermic salt. The user then inserts the shaft of the device into the anal canal (for internal hemorrhoids) or applies to the outer tissues (for external hemorrhoids), and squeezes the bag with the aid of the squeezer. This action transfers the cold fluid generated into the balloon, which provides targeted cold therapy to the hemorrhoids. Instalief™ is meant to be used for 6 - 8 minutes.
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