FDA (Devices) recall action 84568
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
This relates to the standard 21 CFR 1040.10(f)(3) requiring a readily available remote interlock connector for the laser device
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Aerolase Corporation is recalling 65 LightPod ERA lasers because they lack a required remote interlock connector, posing a potential safety hazard.
Aerolase Corporation is recalling 649 LightPod Neo Lasers nationwide because they lack a required remote interlock connector.