FDA Device

LightPod ERA lasers

Hazard

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

What You Should Do

Remedy

Aerolase notified all customers to whom such product was delivered. Customer will be informed that the firm plan to provide immediately, and without charge, a remote interlock connector for use with their Aerolase lasers. For questions contact Aerolase in Tarrytown, NY at information@aerolase.com or 914-345-8300.

Products

LightPod ERA lasers
Brand
Aerolase Corporation
UPC
LightPod ERA Lasers

Units Affected

65