TRANSCEND

Electrosurgical, Cutting & Coagulation & Accessories

SYNERON MEDICAL LTD.

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

Pre-market Notification Details

• Device ID: K120510
• 510k Number: K120510
• Device Name: TRANSCEND
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: SYNERON MEDICAL LTD. INDUSTRIAL ZONE, TAVOR BUILDING, P.O.B. 550 Yokneam Illit, IL 20692
• Contact: Sam Wade
• Correspondent: Sam Wade; SYNERON MEDICAL LTD. INDUSTRIAL ZONE, TAVOR BUILDING, P.O.B. 550 Yokneam Illit, IL 20692
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-02-21
• Decision Date: 2013-07-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
17290109952705	K120510	000
07290109950396	K120510	000
37290109950434	K120510	000
37290109950427	K120510	000
37290109950410	K120510	000
17290109952212	K120510	000
17290109950430	K120510	000
17290109950423	K120510	000
17290109950416	K120510	000
07290109950402	K120510	000
07290109950419	K120510	000
07290109950426	K120510	000
17290109952694	K120510	000
07290109952215	K120510	000
07290109952031	K120510	000
07290109952024	K120510	000
07290109951867	K120510	000
07290109951751	K120510	000
07290109950808	K120510	000
07290109950433	K120510	000
00817495024455	K120510	000