Surgical Green Laser System

Powered Laser Surgical Instrument

Realton (Suzhou) Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Realton (suzhou) Medical Technology Co., Ltd. with the FDA for Surgical Green Laser System.

Pre-market Notification Details

Device IDK202828
510k NumberK202828
Device Name:Surgical Green Laser System
ClassificationPowered Laser Surgical Instrument
Applicant Realton (Suzhou) Medical Technology Co., Ltd. 601 Room, B8 Building, 218 Xinghu Road, Suzhou Industrial Park Suzhou,  CN 215123
ContactMingzhu Liu
CorrespondentOlivia Meng
Guangzhou Osmunda Medical Device Technical Services Co.,Ltd. 8-9Th Floor, R&D Building, No.26 Qinglan St, Panyu District Guangzhou,  CN 510006
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-24
Decision Date2021-06-04

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