AC applicator AS13843R

GUDID 07290109951270

Elos-AC Applicator

SYNERON MEDICAL LTD

Multi-modality skin surface treatment system
Primary Device ID07290109951270
NIH Device Record Keyd41a3143-e3fc-491c-9436-58fda0d4a68a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAC applicator
Version Model NumberAS13843R
Catalog NumberAS13843R
Company DUNS532685716
Company NameSYNERON MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109951270 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-22

On-Brand Devices [AC applicator]

07290109951614AC Applicator, elos Plus
07290109951270Elos-AC Applicator
07290109950907AC Applicator, elos Plus  
07290109950068Elos-AC Applicator

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