510(k) Report

FDA applicant

Omm Imports Inc Dba Zero Gravity

Hallandle, FL1 decision2016–20160 recalls

FDA records 1 decision for Omm Imports Inc Dba Zero Gravity (Hallandle, FL) in 2016: 1 510(k) clearance. All are in product code OHS (Light Based Over The Counter Wrinkle Reduction). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Omm Imports Inc Dba Zero Gravity’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Omm Imports Inc Dba Zero Gravity by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Omm Imports Inc Dba Zero Gravity’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • OHSLight Based Over The Counter Wrinkle Reduction1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity · 20163cite it

What has FDA decided for it lately?

  • K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity · 2016

The one decision as Omm Imports Inc Dba Zero Gravity →