Sparkling

Powered Laser Surgical Instrument

Shanghai Wonderful Opto-Electrics Tech. Co., Ltd

The following data is part of a premarket notification filed by Shanghai Wonderful Opto-electrics Tech. Co., Ltd with the FDA for Sparkling.

Pre-market Notification Details

• Device ID: K163655
• 510k Number: K163655
• Device Name: Sparkling
• Classification: Powered Laser Surgical Instrument
• Applicant: Shanghai Wonderful Opto-Electrics Tech. Co., Ltd 2F, Building 3, Lane 561, Nujiang Road (North), Shanghai, CN
• Contact: Amy Lee
• Correspondent: Jonathan Hu; Medwheat (Shanghai) Medical Technology Co., Ltd. Yangpu District Liaoyuan East Road Shuangyang First Suite NO.33 Room 303 Shanghai, CN 200093
• Product Code: GEX
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-12-23
• Decision Date: 2017-03-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06972693080017	K163655	000