510(k) Report

FDA applicant

Shanghai Omni Laser Skinology Co., Ltd.

Shanghai, CN3 decisions2023–20230 recalls

FDA records 3 decisions for Shanghai Omni Laser Skinology Co., Ltd. (Shanghai, CN) in 2023: 3 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and ONF (Powered Light Based Non-Laser Surgical…). Since 2016 its 510(k)s took a median of 189 days from receipt to decision, against 87 for FDA’s reviews in the same codes and years. Its devices cite 6 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 Shanghai Omni Laser Skinology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2023

2023: 3
2023high 3 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Shanghai Omni Laser Skinology Co., Ltd. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shanghai Omni Laser Skinology Co., Ltd.’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?

  • GEXPowered Laser Surgical Instrument2decisions
  • 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 189 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 87 days; 0 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:

What has FDA decided for it lately?

  • K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd. · 2023
  • K223778Diode Laser Hair Removal System (RD-SLD600)Shanghai Omni Laser Skinology Co., Ltd. · 2023
  • K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd. · 2023

All 3 as Shanghai Omni Laser Skinology Co., Ltd. →