Class Class II

AGNES Ultra (K250217)

K250217 2025-09-03 Traditional
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Description

AGNES Ultra by Agnes Medical Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250217
Clearance Date2025-09-03
Clearance TypeTraditional
Product CodeGEI
Regulation Number878.4400

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