FDA Enforcement
Class II
Ongoing
Lazervida 10W diode laser cutter and engraver with Lazervida shield.
Recall: Z-1878-2025
·
Reported June 11, 2025
Enforcement
- Recall Number
- Z-1878-2025
- Event ID
- 96935
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Flux Technology Inc.
- Voluntary / Mandated
- FDA Mandated
- Initial Notification
- Letter
- Report Date
- June 11, 2025
- Initiation Date
- February 19, 2025
- Classification Date
- June 3, 2025
- Address
- 9 F; No. 465 Zhongxiao E. Rd., Sec. 6, Nangang District, Taipei City, N/A, N/A, Taiwan
Description
Lazervida 10W diode laser cutter and engraver with Lazervida shield.
Reason
Lazervida 10W Diode Laser Engraver does not fully meet current Federal performance standards in certain areas. Specifically, the product does not incorporate the additional beam attenuator, remote interlock connector, key switch, specific labels and manual instructions required under current regulations.
Code Info
None.
Distribution
US
Quantity
91