Lazervida 10W Diode Laser Engraver Does Not Meet Federal Safety Standards
Flux Technology Inc. is recalling the Lazervida 10W diode laser cutter and engraver because it does not fully meet current Federal performance standards for laser device safety features and labeling.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The source identifies this as an FDA Class II recall. The recall is based on non-compliance with Federal performance standards (missing safety features and required labeling) rather than an actual injury or illness report. No adverse events are reported in the source text.
Plain-English summary
Flux Technology Inc. is recalling the Lazervida 10W diode laser cutter and engraver with Lazervida shield. The product does not incorporate required safety features and compliance elements mandated under current Federal regulations.
Specifically, the device is missing the following required components and features: an additional beam attenuator, a remote interlock connector, a key switch, specific required labels, and manual instructions as specified in current regulations. These omissions mean the product does not fully meet current Federal performance standards.
Consumers who own the Lazervida 10W diode laser engraver should stop using the device and contact Flux Technology Inc. for further instructions regarding the recall.
The recalled product
- Product
- Lazervida 10W diode laser cutter and engraver with Lazervida shield.
- Manufacturer
- Flux Technology Inc.
- Category
- Medical Device — Laser Equipment
- Affected units
- 91
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- None.
Distribution
Distribution scope not specified by the agency.
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