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510(k) Data Aggregation
K Number
K992536Device Name
TECHNOSANAT KRYO TSK 2005
Manufacturer
Date Cleared
1999-10-08
(71 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
TECHNOSANAT INNOVATIVE MEDIZINTECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
TECHNOSANAT KRYO TSK 2005 is intended for use in conjunction with a laser to provide surface cooling during cutaneous laser treatment and is a cooling device indicated for:
1. The reduction of pain associated with laser treatment,
2. Less discomfort.
3. Cooling of the skin just before laser impulse treatment.
Device Description
TECHNOSANAT KRYO TSK 2005 is a skin-cooling device designed for support of laser treatment. The device consists of a control device and the treatment applicator which are connected via hose lines. Cold is generated in the applicator by means of Peltierelement, and directed to the patient via a metallic finger transfer medium. A piece of cooled metal comes in contact with skin and performs skin cooling. The treatment temperature is recorded by means of one temperature sensor in the applicator and is then displayed on the device's temporatur controllar
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