510(k) Report

FDA applicant

Ulike Co., Ltd.

Seoul, KR3 decisions2022–20240 recalls

FDA records 3 decisions for Ulike Co., Ltd. (Seoul, KR) from 2022 to 2024: 3 510(k) clearances. Most are in product codes OHT (Light Based Over-The-Counter Hair Removal) and ONF (Powered Light Based Non-Laser Surgical…). Since 2016 its 510(k)s took a median of 107 days from receipt to decision, against 70 for FDA’s reviews in the same codes and years. Its devices cite 6 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, general and plastic surgery panel, where it files most

How often FDA has decided Ulike Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2022: 22024: 1
2022high 2 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Ulike Co., Ltd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ulike 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
  • ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 107 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 70 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 6 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.

  • K213558IPL Hair Removal DeviceUlike Co., Ltd. · 20222cite it
  • K221553Diamond Air+ (UI04A, UI04B, UI04C)Ulike Co., Ltd. · 20221cites it

What has FDA decided for it lately?

  • K243030Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)Ulike Co., Ltd. · 2024
  • K221553Diamond Air+ (UI04A, UI04B, UI04C)Ulike Co., Ltd. · 2022
  • K213558IPL Hair Removal DeviceUlike Co., Ltd. · 2022

All 3 as Ulike Co., Ltd. →