510(k) Report

FDA applicant

Shenzhen Mareal Tech Co., Ltd.

Shenzhen, CN2 decisions2018–20220 recalls

FDA records 2 decisions for Shenzhen Mareal Tech Co., Ltd. (Shenzhen, CN) from 2018 to 2022: 2 510(k) clearances. All are in product code OHT (Light Based Over-The-Counter Hair Removal). Its devices cite 3 predicates, 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 Shenzhen Mareal Tech Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2018: 12022: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Shenzhen Mareal Tech Co., Ltd. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shenzhen Mareal Tech Co., Ltd.’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?

  • OHTLight Based Over-The-Counter Hair Removal2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K220248Home use hair removal deviceShenzhen Mareal Tech Co., Ltd. · 20222cite it

What has FDA decided for it lately?

  • K220248Home use hair removal deviceShenzhen Mareal Tech Co., Ltd. · 2022
  • K172883Home Use Hair Removal Device/T1, T2, T3Shenzhen Mareal Tech Co., Ltd. · 2018

All 2 as Shenzhen Mareal Tech Co., Ltd. →