Class Class II

FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm (K221623)

K221623 2023-03-10 Traditional
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Description

FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm by Gme German Medical Engineering GmbH — FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK221623
Clearance Date2023-03-10
Clearance TypeTraditional
Product CodeGEX
Regulation Number878.4810

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