Recall Z-1878-2025— Flux Technology Inc.
Class II · Ongoing
Class II FDA medical device recall by Flux Technology Inc., initiated 2025-02-19. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Flux Technology Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-02-19
- Firm location
- Taipei City, N/A, Taiwan
Product description
Lazervida 10W diode laser cutter and engraver with Lazervida shield.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.