Recall Z-1489-2018— Beijing Syntech Laser Co., Ltd
Class II · Ongoing
Class II FDA medical device recall by Beijing Syntech Laser Co., Ltd, initiated 2017-07-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Beijing Syntech Laser Trixel C02 Laser surgical lasers. 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"..
- Recalling firm
- Beijing Syntech Laser Co., Ltd
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2017-07-03
- Firm location
- Beijing, N/A, China
Product description
Beijing Syntech Laser Trixel C02 Laser surgical lasers
Reason for recall
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".
Data sourced from openFDA. This site is unofficial and independent of the FDA.