Cleared Traditional

K220549 - MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014 (FDA 510(k) Clearance)

K220549 · Hans Biomed Corporation · General & Plastic Surgery device

Mar 2023

Decision

375d

Days

Class 2

Risk

K220549 is an FDA 510(k) clearance for the MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014. This device is classified as a Suture, Surgical, Absorbable, Polydioxanone (Class II - Special Controls, product code NEW).

Submitted by Hans Biomed Corporation (Yuseong-Gu, KR). The FDA issued a Cleared decision on March 7, 2023, 375 days after receiving the submission on February 25, 2022.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4840.

Submission Details

510(k) Number	K220549 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 25, 2022
Decision Date	March 07, 2023
Days to Decision	375 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF