IPL Therapy Machine

Powered Light Based Non-laser Surgical Instrument With Thermal Effect

BEIJING ADSS DEVELOPMENT CO., LTD

The following data is part of a premarket notification filed by Beijing Adss Development Co., Ltd with the FDA for Ipl Therapy Machine.

Pre-market Notification Details

Device IDK161286
510k NumberK161286
Device Name:IPL Therapy Machine
ClassificationPowered Light Based Non-laser Surgical Instrument With Thermal Effect
Applicant BEIJING ADSS DEVELOPMENT CO., LTD F6, XIANDAO BLDG.,JINYUAN RD. 36, DAXING ECONOMIC DAXING ECONOMIC DEVELOPMENT ZONE Beijing,  CN 102628
ContactYurong Gao
CorrespondentRay Wang
BEIJING BELIEVE TECHNOLOGY SERVICES CO., LTD. 5-1206, BUILD 332, DAFANGJU, NO.25 BANBIDIAN RD. Liyuan Town, Tongzhou District, Beijing,  CN 101121
Product CodeONF  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-05-09
Decision Date2016-08-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06970453270005 K161286 000
06970453270043 K161286 000
00850062978003 K161286 000

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