BM.IRIS

Powered Laser Surgical Instrument

Bluecore Co.,Ltd.

The following data is part of a premarket notification filed by Bluecore Co.,ltd. with the FDA for Bm.iris.

Pre-market Notification Details

Device IDK171648
510k NumberK171648
Device Name:BM.IRIS
ClassificationPowered Laser Surgical Instrument
Applicant Bluecore Co.,Ltd. Acehigh 21, 48 Centum-Jungang Ro 128 Haeundae-gu,  KR
ContactBill Choi
CorrespondentYoung Chi
Bio-Med USA Inc 111 Ellison Street Paterson,  NJ  07446
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-05
Decision Date2017-09-08
Summary:summary

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