Aerolase LightPod ERA Lasers Recalled for Missing Remote Interlock Connector
Aerolase Corporation is recalling 65 LightPod ERA lasers because they lack a required remote interlock connector, posing a potential safety hazard.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a laser safety defect (missing interlock) which poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Aerolase Corporation is recalling 65 units of LightPod ERA lasers distributed nationwide in the United States. The recall was initiated because the devices do not comply with the standard 21 CFR 1040.10(f)(3), which requires a readily available remote interlock connector for laser devices.
The missing remote interlock connector is a safety feature designed to prevent accidental laser exposure. The source text does not report any specific injuries, illnesses, or deaths associated with this recall. The agency has classified this recall as Class II.
Consumers who possess these devices should stop using them immediately and contact Aerolase Corporation for instructions on how to proceed with the recall.
The recalled product
- Product
- LightPod ERA lasers
- Manufacturer
- Aerolase Corporation
- Category
- Medical Device — Laser Device
- Hazard
- Affected units
- 65
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 ERA 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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See all →- ModerateAerolase LightPod Neo Lasers Recalled for Missing Remote Interlock Connector
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