Class Class II

JOULE 1064nm System and Accessories (K251077)

K251077 2025-12-19 Traditional
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Description

JOULE 1064nm System and Accessories by Sciton, Inc., an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251077
Clearance Date2025-12-19
Clearance TypeTraditional
Product CodeGEX
Regulation Number878.4810

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