Data / Medical devices / United States / Omm Imports, Inc. D/B/A Zero Gravity

Omm Imports, Inc. D/B/A Zero Gravity: FDA-registered device maker in Miami Beach, FL, United States, 4 510(k) clearances

Name: Omm Imports, Inc. D/B/A Zero Gravity FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Omm Imports, Inc. D/B/A Zero Gravity is registered with the FDA (registration 3012327767) in Miami Beach, FL, United States. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 16, 2019. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012327767
Address: 940 Lincoln Rd, Miami Beach, FL, United States, 33139
Owner or operator: Omm Imports, Inc. d/b/a Zero Gravity (10051405)
Roles: Complaint file establishment
First device listed: March 1, 2019
Registered through: 2026
Brand names listed: Clearist, Elevare Limited, Elevare Plus, Genesis Skye, Genesis Z, Glorifico, Glorifico Plus, Ivory and more

Devices it lists

Device	Product code	Class	Role	Source
Lamp, Infrared, Therapeutic Heating	ILY	2	Complaint file establishment	accessdata.fda.gov
Laser, Comb, Hair	OAP	2	Complaint file establishment	accessdata.fda.gov
Light Based Over The Counter Wrinkle Reduction	OHS	2	Complaint file establishment	accessdata.fda.gov
Over-The-Counter Powered Light Based Laser For Acne	OLP	2	Complaint file establishment	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 16, 2019	K183329	Laser Hair Therapy	OAP	Substantially Equivalent	Omm Imports, Inc. D/B/A Zero Gravity	accessdata.fda.gov
June 7, 2018	K172909	ELEVARE, PERFECTIO 4	OHS	Substantially Equivalent	Omm Imports D/B/A Zero Gravity	accessdata.fda.gov
May 1, 2018	K172555	SAPPHIRE, ELEVARE SAPPHIRE	OLP	Substantially Equivalent	Omm Imports, Inc. D/B/A Zero Gravity	accessdata.fda.gov
February 25, 2016	K152332	Perfectio LED infrared device	OHS	Substantially Equivalent	Omm Imports Inc Dba Zero Gravity	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
September 1, 2022	91839	Class II	Ongoing	Recreo Hair Growth Laser Comb	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.	accessdata.fda.gov

Compare with other makers

Updated March 14, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.