Aerolase LightPod Neo Lasers Recalled for Missing Remote Interlock Connector
Aerolase Corporation is recalling 649 LightPod Neo Lasers nationwide because they lack a required remote interlock connector.
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 recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a regulatory compliance issue regarding a safety feature, fitting the criteria for a moderate severity score.
Plain-English summary
Aerolase Corporation is recalling 649 units of LightPod Neo Lasers distributed nationwide in the United States. The recall is being conducted by the U.S. Food and Drug Administration.
The recall is due to a compliance issue with 21 CFR 1040.10(f)(3), which requires laser devices to have a readily available remote interlock connector. The recalled units do not meet this specific regulatory requirement.
Consumers and healthcare providers who possess these devices should stop using them and contact Aerolase Corporation for further instructions on how to resolve the issue.
The recalled product
- Product
- LightPod Neo Lasers
- Manufacturer
- Aerolase Corporation
- Category
- Medical Device — Laser Device
- Affected units
- 649
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)
- LightPod Neo Lasers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Aerolase Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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