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Terminated

LightPod ERA lasers

FDA Recall Z-0768-2020 · Posted None

Recalling FirmAerolase Corporation
Recall StatusTerminated
Product CodeGEX
Date Initiated2019-08-01
Date Terminated2021-03-30
Product Quantity65

Reason for Recall

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

Firm Action

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 [email protected] or 914-345-8300.

Distribution Pattern

US Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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