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U.S. Department of Health and Human Services

Class 2 Device Recall Aerolase Laser

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  Class 2 Device Recall Aerolase Laser see related information
Date Initiated by Firm August 01, 2019
Create Date January 03, 2020
Recall Status1 Terminated 3 on March 30, 2021
Recall Number Z-0769-2020
Recall Event ID 84568
Product Classification Powered laser surgical instrument - Product Code GEX
Product LightPod Neo Lasers
Code Information LightPod Neo Lasers
Recalling Firm/
Manufacturer		 Aerolase Corporation
777 Old Saw Mill River Rd Ste 205
Tarrytown NY 10591-6703
For Additional Information Contact
914-345-8300
Manufacturer 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
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 information@aerolase.com or 914-345-8300.
Quantity in Commerce 649
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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