Recall Z-1222-2023— OMM Imports, Inc. dba Zero Gravity

Name: FDA recall Z-1222-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-01

Class II · Ongoing

Class II FDA medical device recall by OMM Imports, Inc. dba Zero Gravity, initiated 2022-09-01. It names one FDA 510(k) clearance: K183329. Product: Recreo Hair Growth Laser Comb. Reason: 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..

Recalling firm: OMM Imports, Inc. dba Zero Gravity
Classification: Class II
Status: Ongoing
Initiated: 2022-09-01
Firm location: Miami Beach, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K183329 — Laser Hair TherapyOmm Imports, Inc. D/B/A Zero Gravity·cleared 2019-01-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Recreo Hair Growth Laser Comb

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.