FDA-Device2018-05-09Class II
Beijing Syntech Laser UL C02 Laser surgical lasers
Beijing Syntech Laser Co., Ltd
Hazard
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".
Sold states
US Distribution
Affected count
92
Manufactured in
International Industry Base, West Area F/4; No. 8 Liye Road; Changping, Beijing, N/A, China
Products
Beijing Syntech Laser UL C02 Laser surgical lasers
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1491-2018Don't want to check this manually?
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