510(k) Report

FDA applicant

Loktal Medical Electronics Ind. Com. Ltda- Epp

Austin, TX1 decision2015–20150 recalls

FDA records 1 decision for Loktal Medical Electronics Ind. Com. Ltda- Epp (Austin, TX) in 2015: 1 510(k) clearance. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 2 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 Loktal Medical Electronics Ind. Com. Ltda- Epp’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Loktal Medical Electronics Ind. Com. Ltda- Epp by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Loktal Medical Electronics Ind. Com.…’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?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K134036Wavetronic 5000 Digital HF Surgical UnitLoktal Medical Electronics Ind. Com. Ltda- Epp · 2015

The one decision as Loktal Medical Electronics Ind. Com. Ltda- Epp →