510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Beijing Syntech Laser Co., Ltd

Beijing, CN

BEIJING SYNTECH LASER CO., LTD. appears in FDA device records in Beijing, CN. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
3
PMA records
0
Recall records
8
Registered establishments
1

510(k) clearance history

FDA records hold 3 510(k) clearances for Beijing Syntech Laser Co., Ltd between 2011 and 2013. The busiest year on record is 2011, with 1. The most recent is 2013, with 1.

Clearances by year, as a table
510(k) clearance decisions for Beijing Syntech Laser Co., Ltd, by decision year
YearClearances
20111
20121
20131
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K123483DIODE LASERGEXSubstantially Equivalent
K113018APOLLO V+ MEDICAL PLATFORM, APOLLO IV+ MEDICAL PLATFORM, NICE STATION LIGHT BASED PLATFORMGEXSubstantially Equivalent
K110434TRIXEL CO2 LASERGEXSubstantially Equivalent

Registered establishments

FDA registered establishments for Beijing Syntech Laser Co., Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30075357343007535734BEIJING SYNTECH LASER CO., LTD.4/F West Area,1#Building, Beijing 102206 CN2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1495-2018Beijing Syntech Laser UL Station surgical lasersThe noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".Class IIOpen, Classified
Z-1494-2018Beijing Syntech Laser Nice Station Light Based Platform surgical lasersThe noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".Class IIOpen, Classified
Z-1493-2018Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasersThe noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".Class IIOpen, Classified
Z-1492-2018Beijing Syntech Laser APOLLO V+ Medical Platform surgical lasersThe noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".Class IIOpen, Classified
Z-1491-2018Beijing Syntech Laser UL C02 Laser surgical lasersThe noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".Class IIOpen, Classified
Z-1490-2018Beijing Syntech Laser Trixel 11 C02 Laser surgical lasersThe noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".Class IIOpen, Classified
Z-1489-2018Beijing Syntech Laser Trixel C02 Laser surgical lasersThe noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".Class IIOpen, Classified
Z-1488-2018Beijing Syntech Laser Diode Laser surgical lasersThe noncompliance is that the certification label was not affixed on the product, with statement "Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007".Class IIOpen, Classified

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Data as of , FDA export datePage updated Source: openFDA, public domain