CO2 Laser System

Powered Laser Surgical Instrument

Smedtrum Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Smedtrum Medical Technology Co., Ltd. with the FDA for Co2 Laser System.

Pre-market Notification Details

Device IDK221597
510k NumberK221597
Device Name:CO2 Laser System
ClassificationPowered Laser Surgical Instrument
Applicant Smedtrum Medical Technology Co., Ltd. 1F., No. 8, Ln. 97, Wugong Rd., New Taipei City,  TW 248016
ContactCrimson Wu
CorrespondentCrimson Wu
Smedtrum Medical Technology Co., Ltd. 1F., No. 8, Ln. 97, Wugong Rd., New Taipei City,  TW 248016
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-06-02
Decision Date2022-09-15

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