Cleared Traditional

1060nm laser body slimming machine

K240658 · Hebei JT Medical Co., Ltd. · General & Plastic Surgery

May 2024

Decision

66d

Days

Class 2

Risk

About This 510(k) Submission

K240658 is an FDA 510(k) clearance for the 1060nm laser body slimming machine, a Laser For Disruption Of Adipocyte Cells For Aesthetic Use (Class II — Special Controls, product code PKT), submitted by Hebei JT Medical Co., Ltd. (Hebei, CN). The FDA issued a Cleared decision on May 13, 2024, 66 days after receiving the submission on March 8, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5400.

Submission Details

510(k) Number	K240658 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 08, 2024
Decision Date	May 13, 2024
Days to Decision	66 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	PKT — Laser For Disruption Of Adipocyte Cells For Aesthetic Use
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.5400
Definition	Laser Intended For The Disruption Of Adipocyte Cells Indicated For Body Contouring Or Reduction In Circumference Of Body Areas.