ORION

Powered Laser Surgical Instrument

YERIM ENGINEERING Co., Ltd.

The following data is part of a premarket notification filed by Yerim Engineering Co., Ltd. with the FDA for Orion.

Pre-market Notification Details

• Device ID: K161503
• 510k Number: K161503
• Device Name: ORION
• Classification: Powered Laser Surgical Instrument
• Applicant: YERIM ENGINEERING Co., Ltd. Ga-307, Techno-zone ,117, Hwanggeum-ro, Yangchon-eup Gimpo-si, KP 415843
• Contact: Won Gil Jeon
• Correspondent: Priscilla Chung; LK Consulting Group USA, Inc. 800 ROOSEVELT STE 417 Irvine, CA 92620
• Product Code: GEX
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-06-01
• Decision Date: 2016-08-26
• Summary: summary