SensiLift

Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction

EL GLOBAL TRADE LTD

The following data is part of a premarket notification filed by El Global Trade Ltd with the FDA for Sensilift.

Pre-market Notification Details

• Device ID: K170499
• 510k Number: K170499
• Device Name: SensiLift
• Classification: Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction
• Applicant: EL GLOBAL TRADE LTD 8 Tzoran St, P.O. Box 8242 Netanya, IL 4250608
• Contact: Yael Liebes-peer
• Correspondent: Yael Liebes-peer; EL GLOBAL TRADE LTD 8 Tzoran St, P.O. Box 8242 Netanya, IL 4250608
• Product Code: PAY
• CFR Regulation Number: 878.4420 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-02-17
• Decision Date: 2017-06-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05060445341255	K170499	000
05060445341125	K170499	000