510(k) Report

FDA applicant

Y & J Bio Co., Ltd.

Hanam-Si, KR5 decisions2018–20220 recalls

FDA records 5 decisions for Y & J Bio Co., Ltd. (Hanam-Si, KR) from 2018 to 2022: 5 510(k) clearances. Most are in product codes OAP (Laser, Comb, Hair) and OHS (Light Based Over The Counter Wrinkle Reduction). Since 2016 its 510(k)s took a median of 85 days from receipt to decision, against 88 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 2 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, physical medicine panel, where it files most

How often FDA has decided Y & J Bio Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2022

2018: 22020: 12022: 2
2018high 2 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Y & J Bio Co., Ltd. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Y & J Bio 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?

  • OAPLaser, Comb, Hair3decisions
  • OHSLight Based Over The Counter Wrinkle Reduction2decisions

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 85 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 88 days; 3 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K213285easy ClaireY & J Bio Co., Ltd. · 20222cite it
  • K180617Hair UpY & J Bio Co., Ltd. · 20181cites it

What has FDA decided for it lately?

  • K223278easy ClaireY & J Bio Co., Ltd. · 2022
  • K213285easy ClaireY & J Bio Co., Ltd. · 2022
  • K202983easy HairfullY & J Bio Co., Ltd. · 2020
  • K180617Hair UpY & J Bio Co., Ltd. · 2018
  • K172968Hair UpY & J Bio Co., Ltd. · 2018

All 5 as Y & J Bio Co., Ltd. →