Is Beijing Syntech Laser Diode Laser surgical lasers recalled?

Medium RiskFDA Device

Beijing Syntech Laser Co., Ltd: 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".

Agency Publication Date: May 2, 2018

Affected Products

Product: Beijing Syntech Laser Diode Laser surgical lasers

Model Diode Laser

Product: Beijing Syntech Laser Trixel C02 Laser surgical lasers

Model Trixel C02 Laser

Product: Beijing Syntech Laser Trixel 11 C02 Laser surgical lasers

Model Trixel 11 C02 Laser

Product: Beijing Syntech Laser UL C02 Laser surgical lasers

Model UL C02 Laser

Product: Beijing Syntech Laser APOLLO V+ Medical Platform surgical lasers

Model Apollo V + Medical Platform

Product: Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers

Model APOLLO 1V+Medical Platform

Product: Beijing Syntech Laser Nice Station Light Based Platform surgical lasers

Model Nice Station Light Based Platform

Product: Beijing Syntech Laser UL Station surgical lasers

Model UL Station

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79697

Status: Active

Manufacturer: Beijing Syntech Laser Co., Ltd

Manufactured In: China

Units Affected: 8 products (13; 38; 3; 92; 11; 6; 7; 199)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.