| 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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