Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6

Powered Laser Surgical Instrument

ADVANCED TECHNOLOGY LASER CO., LTD.

The following data is part of a premarket notification filed by Advanced Technology Laser Co., Ltd. with the FDA for Q-switched Nd:yag Laser System, Model Globalcure-sc6.

Pre-market Notification Details

Device IDK102050
510k NumberK102050
Device Name:Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6
ClassificationPowered Laser Surgical Instrument
Applicant ADVANCED TECHNOLOGY LASER CO., LTD. LN 999, ZHONGSHAN #2 RD (S) SUITE 5D, NO 19 Shanghai,  CN 200030
ContactDiana Hong
CorrespondentCasey Conry
UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville,  NY  11747
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2010-07-21
Decision Date2010-07-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06970507240206 K102050 000

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