E>EyeC

Powered Light Based Non-laser Surgical Instrument With Thermal Effect

E-SWIN

The following data is part of a premarket notification filed by E-swin with the FDA for E>eyec.

Pre-market Notification Details

Device IDK200616
510k NumberK200616
Device Name:E>EyeC
ClassificationPowered Light Based Non-laser Surgical Instrument With Thermal Effect
Applicant E-SWIN Rue Des Cotes D'orval, ZA De La Prevote Houdan,  FR 78550
ContactEmeric Obin
CorrespondentEmeric Obin
E-SWIN Rue Des Cotes D'orval, ZA De La Prevote Houdan,  FR 78550
Product CodeONF  
Subsequent Product CodeGEX
Subsequent Product CodeONG
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-09
Decision Date2020-06-11

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