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Recall Observatory FDA recall evidence

Device product

LightPod Neo Lasers

Z-0769-2020

August 01, 2019

Class II

Product summary

Firm
Aerolase Corporation
Event
Event 84568
Status
Terminated
Classification
Class II
Quantity
649
Official record key
device-enforcement:Z-0769-2020

Official wording

Reason: This relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock connector for the laser device

Code information: LightPod Neo Lasers

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    This relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock connector for the laser device