Consumer health companyLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list OMM Imports (Zero Gravity) with 4 510(k) clearances and 1 device recall. The most recent is a device recall dated Sep 1, 2022: Recreo Hair Growth Laser Comb.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 1, 2022 | Recreo Hair Growth Laser CombClass II · The firm distributed the laser products without affixing the warning, aperture, certification, and identification labels | Device recalls |
| Jan 16, 2019 | Laser Hair TherapyK183329 · OAP | 510(k) clearances |
| Jun 7, 2018 | ELEVARE, PERFECTIO 4K172909 · OHS | 510(k) clearances |
| May 1, 2018 | SAPPHIRE, ELEVARE SAPPHIREK172555 · OLP | 510(k) clearances |
| Feb 25, 2016 | Perfectio LED infrared deviceK152332 · OHS | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
