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Omm Imports, Inc. D/B/A Zero Gravity

3 FDA records filed under this company name, from 2016 to 2019, in hair growth (OAP, 1), light for acne (OLP, 1), light for wrinkles (OHS, 1).

Also filed with slightly different spelling: “Omm Imports Inc Dba Zero Gravity”. We group names that differ only in capitals, spacing or punctuation.

The applicant is the company that filed with FDA. It can be the brand you know or a manufacturer that makes devices sold under other brand names; the device name as filed often shows which. We don't merge different company names, so check the A–Z list for related entries.

Laser and LED hair-growth caps, helmets and combs (1 record says prescription use) (OAP, 1)

510(k) cleared

Laser Hair Therapy

510(k) number
K183329
Applicant
Omm Imports, Inc. D/B/A Zero Gravity
Product code
OAP: Laser, Comb, Hair
Regulation
21 CFR 890.5500, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“Laser Hair Therapy is indicated to promote hair growth in males with androgenic alopecia who have Norwood-Hamilton classifications of IIa-V or females with androgenic alopecia who have Ludwig-Savin Classifications of I-4, II-1, II-2, or frontal and both with Fitzpatrick Skin Phototypes I-IV.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

FDA database recordFDA document (PDF)

LED and light devices for acne (OLP, 1)

510(k) cleared

SAPPHIRE, ELEVARE SAPPHIRE

510(k) number
K172555
Applicant
Omm Imports, Inc. D/B/A Zero Gravity
Product code
OLP: Over-The-Counter Powered Light Based Laser For Acne
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“The SAPPHIRE is an over –the -counter hand held, battery operated, light therapy device that uses light emitting diodes (LEDs) that emit a specific wavelength of 415nm (Blue Light) that is intended for use in the treatment of mild to moderate inflammatory acne.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

FDA database recordFDA document (PDF)

LED and light devices for wrinkles (OHS, 1)

510(k) cleared

Perfectio LED infrared device

510(k) number
K152332
Applicant
Omm Imports Inc Dba Zero Gravity
Product code
OHS: Light Based Over The Counter Wrinkle Reduction
Regulation
21 CFR 878.4810, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“Perfectio LED infrared device is an over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.

FDA database recordFDA document (PDF)