510(k) Report

FDA applicant

Shenzhen Lifotronic Technology Co., Ltd.

Shenzhen, CN3 decisions2020–20260 recalls

FDA records 3 decisions for Shenzhen Lifotronic Technology Co., Ltd. (Shenzhen, CN) from 2020 to 2026: 3 510(k) clearances. Most are in product codes IRP (Massager, Powered Inflatable Tube) and GEX (Powered Laser Surgical Instrument). Its devices cite 4 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, physical medicine panel, where it files most

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

FDA decisions per year

1in 2025

2020: 12025: 12026 (partial year): 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Shenzhen Lifotronic Technology Co., Ltd. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shenzhen Lifotronic Technology 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?

  • IRPMassager, Powered Inflatable Tube1decision
  • GEXPowered Laser Surgical Instrument1decision
  • PDJHemoglobin A1c Test System1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K260468H100Plus Hemoglobin Testing SystemShenzhen Lifotronic Technology Co., Ltd. · 2026
  • K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd. · 2025
  • K192466Air Compression Therapy SystemShenzhen Lifotronic Technology Co., Ltd. · 2020

All 3 as Shenzhen Lifotronic Technology Co., Ltd. →