E>EYE C

GUDID 03662824000207

E-SWIN

Light-energy skin surface treatment system applicator
Primary Device ID03662824000207
NIH Device Record Key146439cc-8b5f-43c2-aa9d-17b3df440e60
Commercial Distribution StatusIn Commercial Distribution
Brand NameE>EYE C
Version Model NumberD029AF001C08A
Company DUNS267700713
Company NameE-SWIN
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103662824000207 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-12
Device Publish Date2022-04-04

Devices Manufactured by E-SWIN

03662824001846 - TearCheck T2023-03-14
03662824003048 - TearCheck T2023-03-14
03662824000207 - E>EYE C2022-04-12
03662824000207 - E>EYE C2022-04-12

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