Diode Laser Therapy System

Powered Laser Surgical Instrument

BEIJING UNT Technology Co., Ltd

The following data is part of a premarket notification filed by Beijing Unt Technology Co., Ltd with the FDA for Diode Laser Therapy System.

Pre-market Notification Details

Device IDK212978
510k NumberK212978
Device Name:Diode Laser Therapy System
ClassificationPowered Laser Surgical Instrument
Applicant BEIJING UNT Technology Co., Ltd M2-1 Area, Xinggu Development Zone, Pinggu District Beijing,  CN 101200
ContactQianwen Sheng
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai,  CN 200120
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-17
Decision Date2021-11-10

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