LUCID LY

Powered Laser Surgical Instrument

BIO-MED USA INC.

The following data is part of a premarket notification filed by Bio-med Usa Inc. with the FDA for Lucid Ly.

Pre-market Notification Details

Device IDK140837
510k NumberK140837
Device Name:LUCID LY
ClassificationPowered Laser Surgical Instrument
Applicant BIO-MED USA INC. 27 NEW ENGLAND DRIVE Ramsey,  NJ  07446
ContactYoung Chi
CorrespondentYoung Chi
BIO-MED USA INC. 27 NEW ENGLAND DRIVE Ramsey,  NJ  07446
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-04-02
Decision Date2014-09-24
Summary:summary

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