510(k) Report

FDA applicant

Micro-Energy Medical Technology Co., Ltd.

Shenzhen, CN3 decisions2025–20260 recalls

FDA records 3 decisions for Micro-Energy Medical Technology Co., Ltd. (Shenzhen, CN) from 2025 to 2026: 3 510(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 4 predicates, 1 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 Micro-Energy Medical Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2025: 22026 (partial year): 1
2025high 2 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Micro-Energy Medical Technology Co., Ltd. by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Micro-Energy Medical Technology Co.…’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?

  • GEXPowered Laser Surgical Instrument3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 90 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K252745Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)Micro-Energy Medical Technology Co., Ltd. · 20251cites it

What has FDA decided for it lately?

  • K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd. · 2026
  • K252745Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)Micro-Energy Medical Technology Co., Ltd. · 2025
  • K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd. · 2025

All 3 as Micro-Energy Medical Technology Co., Ltd. →