LIPOcel

Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption

Jeisys Medical, Inc.

The following data is part of a premarket notification filed by Jeisys Medical, Inc. with the FDA for Lipocel.

Pre-market Notification Details

• Device ID: K181896
• 510k Number: K181896
• Device Name: LIPOcel
• Classification: Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
• Applicant: Jeisys Medical, Inc. 307, Daeryung Techno Town 8th, Gamasan-ro 96, Geumcheon-Gu Seoul, KR 153-775
• Contact: Sugun Lee
• Correspondent: Parul Chansoria; Elexes Medical Consulting 6494 Tralee Village Dr Dr Dublin, CA 94568
• Product Code: OHV
• CFR Regulation Number: 878.4590 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-07-16
• Decision Date: 2019-10-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08800020100009	K181896	000