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Recall Observatory FDA recall evidence

Device product

Beijing Syntech Laser UL C02 Laser surgical lasers

Z-1491-2018

July 03, 2017

Class II

Product summary

Firm
Beijing Syntech Laser Co., Ltd
Event
Event 79697
Status
Ongoing
Classification
Class II
Quantity
92
Official record key
device-enforcement:Z-1491-2018

Official wording

Reason: The 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".

Code information: Model UL C02 Laser

Distribution pattern: US Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The 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".