FDA applicant

Rhein Laser Technologies Co., Ltd.

Wuhan, CN4 decisions2024–20260 recalls

FDA records 4 decisions for Rhein Laser Technologies Co., Ltd. (Wuhan, CN) from 2024 to 2026: 4 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 5 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 Rhein Laser Technologies Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2024

2024high 3 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Rhein Laser Technologies Co., Ltd. by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Rhein Laser Technologies 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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Other applicant names beginning “Rhein”

FDA records each applicant name separately; these may or may not be the same firm.

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Rhein Laser Technologies Co., Ltd.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Rhein”