Purple swivel lens AS90411

GUDID 07290109950167

Purple swivel lens

SYNERON MEDICAL LTD

Dermatological carbon dioxide laser system
Primary Device ID07290109950167
NIH Device Record Keyffbfc19f-3a79-42ac-b1c8-2e5fcccf36f3
Commercial Distribution StatusIn Commercial Distribution
Brand NamePurple swivel lens
Version Model NumberAS90411
Catalog NumberAS90411
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
GS107290109950167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2016-09-26

Devices Manufactured by SYNERON MEDICAL LTD

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07290109952857 - Intima Sterile 2 Internal + 1 External HP, Accessories Kit2020-02-10 Intima Sterile 2 Internal + 1 External HP, Accessories Kit
07290109952864 - eTwo System2020-02-10 eTwo System
17290109952724 - Regular Internal Handpiece 5-Pack Sterile Single-Use, CO2RE Intima2020-02-10 Regular Internal Handpiece 5-Pack Sterile Single-Use, CO2RE Intima
17290109952823 - External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima2020-02-10 External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima
17290109950379 - Internal, CO2RE Intima2019-02-07 Internal, CO2RE Intima
07290109950167 - Purple swivel lens2019-02-07Purple swivel lens
07290109950167 - Purple swivel lens2019-02-07 Purple swivel lens
07290109950273 - Lens, Gold & Silver2019-02-07 Lens, Gold & Silver Assy, CO2RE

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