Coresculpt & Magsculpt— 510(k) K222400

Substantially Equivalent

K1Med Co., Ltd.

FDA 510(k) clearance K222400 for Coresculpt & Magsculpt, Substantially Equivalent on 2024-02-27. Applicant: K1Med Co., Ltd.. Device class: 2.

Clearance details

Applicant
K1Med Co., Ltd.
Product code
Code NGX
Device class
Class 2
Regulation
21 CFR 890.5850
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Seoul, KR
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