Class Class II

ProSense™ System (DEN220077)

DEN220077 2025-10-03 Direct
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Description

ProSense™ System by Icecure Medical, an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberDEN220077
Clearance Date2025-10-03
Clearance TypeDirect
Product CodeQXW
Regulation Number878.4355

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