Recall Z-2870-2017— X-Laser Llc
Class II · Terminated
Class II FDA medical device recall by X-Laser Llc, initiated 2017-07-24, terminated 2024-04-16. FDA's recall record names no specific 510(k) clearance for this event. Product: X-Laser Laser Light Show projector models Aurora, Caliente Aurora, PSX-400, Mobile Beat Max, Mobile Beat Max MKII, X-Beam, Hawk 500 High-power laser light show projector.. Reason: Failure to comply with performance standard requirements (21 CFR 1040.10(f))when operated in the user accessible auto and music modes of operation.
- Recalling firm
- X-Laser Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-07-24
- Terminated
- 2024-04-16
- Firm location
- Laurel, MD, United States
Product description
X-Laser Laser Light Show projector models Aurora, Caliente Aurora, PSX-400, Mobile Beat Max, Mobile Beat Max MKII, X-Beam, Hawk 500 High-power laser light show projector.
Reason for recall
Failure to comply with performance standard requirements (21 CFR 1040.10(f))when operated in the user accessible auto and music modes of operation
Data sourced from openFDA. This site is unofficial and independent of the FDA.