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U.S. Department of Health and Human Services

Class 2 Device Recall Laser Hair Therapy

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  Class 2 Device Recall Laser Hair Therapy see related information
Date Initiated by Firm September 01, 2022
Date Posted March 14, 2023
Recall Status1 Open3, Classified
Recall Number Z-1222-2023
Recall Event ID 91839
510(K)Number K183329  
Product Classification Laser, comb, hair - Product Code OAP
Product Recreo Hair Growth Laser Comb
Code Information Class 3R Zero Gravity Recreo Hair Growth Laser Comb
Recalling Firm/
Manufacturer		 OMM Imports, Inc. dba Zero Gravity
940 Lincoln Rd Ste 307
Miami Beach FL 33139-2619
For Additional Information Contact Lisa Capote
786-871-5683
Manufacturer Reason
for Recall		 The firm distributed the laser products without affixing the warning, aperture, certification, and identification labels. In addition, the firm failed to provide safety information, reproductions and locations of the labels, and a warning statement in the user manual.
FDA Determined
Cause 2		 Error in labeling
Action Letters were sent to all retailers/distributors and any direct purchasers advising of the affected device nonconformance. The letter informed customers that an updated user manual and the appropriate labels will be provided to correct the error, without charge.
Quantity in Commerce 1620 units shipped to United States
Distribution Worldwide and Nationwide including DC and Puerto Rico
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 = OAP and Original Applicant = OMM Imports, Inc. D/B/A Zero Gravity
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