VELASHAPE

Massager, Vacuum, Light Induced Heating

SYNERON MEDICAL LTD.

The following data is part of a premarket notification filed by Syneron Medical Ltd. with the FDA for Velashape.

Pre-market Notification Details

• Device ID: K071872
• 510k Number: K071872
• Device Name: VELASHAPE
• Classification: Massager, Vacuum, Light Induced Heating
• Applicant: SYNERON MEDICAL LTD. POB 550 Yokneam Elite, IL 20692
• Contact: Yoni Iger
• Correspondent: Yoni Iger; SYNERON MEDICAL LTD. POB 550 Yokneam Elite, IL 20692
• Product Code: NUV
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-07-06
• Decision Date: 2007-08-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07290109952437	K071872	000
07290109950358	K071872	000
07290109950341	K071872	000
07290109950334	K071872	000
07290109950327	K071872	000
07290109950310	K071872	000
07290109950303	K071872	000
07290109950266	K071872	000
07290109950259	K071872	000
07290109950242	K071872	000
37290109952162	K071872	000
37290109950359	K071872	000
37290109950342	K071872	000
07290109950440	K071872	000
07290109950723	K071872	000
07290109950761	K071872	000
07290109952161	K071872	000
07290109952154	K071872	000
07290109951560	K071872	000
07290109951553	K071872	000
07290109951546	K071872	000
07290109951539	K071872	000
07290109951447	K071872	000
07290109951430	K071872	000
07290109951423	K071872	000
07290109951348	K071872	000
07290109951317	K071872	000
07290109951294	K071872	000
17290109952151	K071872	000