Class II — Beijing Syntech Laser Co., Ltd
| Recalling firm | Beijing Syntech Laser Co., Ltd. |
|---|---|
| Registered facility | BEIJING SYNTECH LASER CO., LTD. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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". |
| Product | Beijing Syntech Laser Nice Station Light Based Platform surgical lasers |
| Quantity | 7 |
| Distribution | US Distribution |
| Initiated | 2017-07-03 |
| Classified | 2018-05-02 |
| Recall number | Z-1494-2018 |
| Initiation | FDA Mandated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Beijing Syntech Laser Co., Ltd (Z-1494-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79697/
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