Aerolase recalls LightPod Neo Lasers due to missing remote interlock connector, a safety requirement under 21 CFR 1040.10(f)(3).
This relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock connector for the laser device
Aerolase is recalling LightPod Neo Lasers because they lack a required remote interlock connector, which is a safety feature mandated by federal regulations. This could lead to unintended laser activation and potential injury if the device is used without proper safety controls.
The device requires a remote interlock connector to prevent accidental activation. Without this connector, the laser could activate unexpectedly during use, potentially causing injury to the user or others nearby.
Users of LightPod Neo Lasers are affected. People using the device for medical procedures, especially those with sensitive skin or conditions requiring precise laser treatment, are at higher risk.
Check if your LightPod Neo Lasers have a missing remote interlock connector. The product name is listed as 'LightPod Neo Lasers' in the recall notice.
Verify if your LightPod Neo Lasers have a missing remote interlock connector.
The recall is due to the device lacking a required remote interlock connector, a safety feature mandated by federal regulations under 21 CFR 1040.10(f)(3).
The recall notice does not specify a remedy or action steps beyond checking if the device has a missing remote interlock connector.
The recall notice states the device lacks a required safety feature, which could lead to unintended activation and potential injury, but does not specify the exact risk level.
We’ve drafted a message you can send Aerol:ase to request your refund or repair — edit it as you like.
Subject: Recall Z-0769-2020 — Aerol:ase Aerol:ase Hello, I own a Aerol:ase that is covered by recall Z-0769-2020 from Aerol:ase. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
