TWO SKIN TREATMENT SYSTEM

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 Two Skin Treatment System.

Pre-market Notification Details

Device IDK141507
510k NumberK141507
Device Name:TWO SKIN TREATMENT SYSTEM
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant SYNERON MEDICAL LTD. 1835 MARKET ST, 29TH FLOOR Philadelphia,  PA  19103
ContactJanice M Hogan
CorrespondentJanice M Hogan
SYNERON MEDICAL LTD. 1835 MARKET ST, 29TH FLOOR Philadelphia,  PA  19103
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-06
Decision Date2014-12-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290109952000 K141507 000
00817495024301 K141507 000
00817495024318 K141507 000
00817495024325 K141507 000
00817495024493 K141507 000
00817495024509 K141507 000
00817495025100 K141507 000
00817495023779 K141507 000
00817495023793 K141507 000
07290109951195 K141507 000
07290109950662 K141507 000
07290109950709 K141507 000
37290109951196 K141507 000
07290109950686 K141507 000
07290109950693 K141507 000
07290109951584 K141507 000
07290109951607 K141507 000
00817495022918 K141507 000

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