510(k) Report

FDA applicant

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

Doral, FL3 decisions2018–20191 recall

FDA records 3 decisions for Omm Imports, Inc. D/B/A Zero Gravity (Doral, FL) from 2018 to 2019: 3 510(k) clearances. Most are in product codes OAP (Laser, Comb, Hair) and OLP (Over-The-Counter Powered Light Based Laser For…). Since 2016 its 510(k)s took a median of 250 days from receipt to decision, against 89 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Omm Imports D/B/A Zero Gravity”.

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. D/B/A Zero Gravity’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2018: 22019: 1
2018high 2 (2018) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

1in 2022

2022: 1
2018high 1 (2022) · low 0 (2018)2026

Class I Class II/III not classified

FIG. 1 — Omm Imports, Inc. D/B/A Zero Gravity by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • OAPLaser, Comb, Hair1decision
  • OLPOver-The-Counter Powered Light Based Laser For Acne1decision
  • OHSLight Based Over The Counter Wrinkle Reduction1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 250 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 89 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 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.

  • K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity · 20183cite it
  • K172909Elevare, Perfectio 4Omm Imports D/B/A Zero Gravity · 20183cite it
  • K183329Laser Hair TherapyOmm Imports, Inc. D/B/A Zero Gravity · 20192cite it

What has FDA decided for it lately?

  • K183329Laser Hair TherapyOmm Imports, Inc. D/B/A Zero Gravity · 20191 recall
  • K172909Elevare, Perfectio 4Omm Imports D/B/A Zero Gravity · 2018
  • K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity · 2018

All 2 as Omm Imports, Inc. D/B/A Zero Gravity →The one decision as Omm Imports D/B/A Zero Gravity →

What has been recalled?

1 recall linked to its devices; the latest:

  • K183329Recreo Hair Growth Laser CombSep 1, 2022Class II