Class Class II

SmoothCool HR System (K223685)

K223685 2023-01-04 Special
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Description

SmoothCool HR System by Jeisys Medical, Inc. — FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK223685
Clearance Date2023-01-04
Clearance TypeSpecial
Product CodeGEX
Regulation Number878.4810

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