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U.S. Department of Health and Human Services

Class 2 Device Recall New Era

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  Class 2 Device Recall New Era see related information
Date Initiated by Firm January 29, 2020
Create Date November 17, 2020
Recall Status1 Open3, Classified
Recall Number Z-0440-2021
Recall Event ID 86706
510(K)Number K182604  
Product Classification Powered laser surgical instrument - Product Code GEX
Product Class IV New Era medical laser device
Code Information New Era laser units
Recalling Firm/
Manufacturer		 Inova Lasers LLC
433 5th Ave Fl 6
New York NY 10016-2207
For Additional Information Contact
646-641-9769
Manufacturer Reason
for Recall		 The firm failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standard and certification.
FDA Determined
Cause 2		 Radiation Control for Health and Safety Act
Action Notification by the manufacturer to affected persons, the firm will, without charge, remedy the defect or bring your product into compliance with each applicable Federal Standard in accordance with a plan to be approved by FDA.
Quantity in Commerce 8 units
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.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = Step Up Skin Laser, LLC
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