FDA-Device2023-03-22Class II
Recreo Hair Growth Laser Comb
OMM Imports, Inc. dba Zero Gravity
Hazard
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.
Sold states
Worldwide and Nationwide including DC and Puerto Rico
Affected count
1620 units shipped to United States
Manufactured in
940 Lincoln Rd Ste 307, N/A, Miami Beach, FL, United States
Products
Recreo Hair Growth Laser Comb
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1222-2023Don't want to check this manually?
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