FDA-Device2020-01-15Class II

LightPod ERA lasers

Aerolase Corporation
Hazard

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

Sold states
US Nationwide Distribution
Affected count
65
Manufactured in
777 Old Saw Mill River Rd Ste 205, N/A, Tarrytown, NY, United States
Products
LightPod ERA lasers

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0768-2020

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