Cellene CO2 Laser System

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 Cellene Co2 Laser System.

Pre-market Notification Details

Device IDK182270
510k NumberK182270
Device Name:Cellene CO2 Laser System
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 Received2018-08-22
Decision Date2018-11-02
Summary:summary

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