Class 2 Device Recall Laser Hair Therapy

• Date Initiated by Firm: September 01, 2022
• Date Posted: March 14, 2023
• Recall Status: Open, 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: 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