TRIXEL CO2 LASER

Powered Laser Surgical Instrument

BEIJING SYNTECH LASER CO., LTD.

The following data is part of a premarket notification filed by Beijing Syntech Laser Co., Ltd. with the FDA for Trixel Co2 Laser.

Pre-market Notification Details

Device IDK110434
510k NumberK110434
Device Name:TRIXEL CO2 LASER
ClassificationPowered Laser Surgical Instrument
Applicant BEIJING SYNTECH LASER CO., LTD. P.O. BOX 237-023 Shanghai,  CN 200237
ContactDiana Hong
CorrespondentMarc M Mouser
UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas,  WA  98607 -9526
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2011-02-15
Decision Date2011-04-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06970285179095 K110434 000
06970285179057 K110434 000
06970285179026 K110434 000

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