510(k) Report

FDA applicant

Clinical Laserthermia Systems, AB

Lund, SE6 decisions2015–20251 recall

FDA records 6 decisions for Clinical Laserthermia Systems, AB (Lund, SE) from 2015 to 2025: 6 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and ONO (Neurosurgical Laser With Mr Thermography). Since 2016 its 510(k)s took a median of 247 days from receipt to decision, against 114 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 3 of them its own earlier devices. 1 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 Clinical Laserthermia Systems, AB’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2015: 12016: 12017: 12021: 12022: 12025: 1
2015high 1 (2015) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2021

2021: 1
2015high 1 (2021) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Clinical Laserthermia Systems, AB by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Clinical Laserthermia Systems, AB’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 Instrument4decisions
  • ONONeurosurgical Laser With Mr Thermography2decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 247 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 114 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K214125TRANBERG Thermoguide Therapy SystemClinical Laserthermia Systems, AB · 20222cite it
  • K142216Tranberg CLS Thermal Therapy SystemClinical Laserthermia Systems, AB · 20151cites it
  • K151569Tranberg CLS Laser FiberClinical Laserthermia Systems, AB · 20161cites it
  • K163103Tranberg CLS Diffusor Laser FiberClinical Laserthermia Systems, AB · 20171cites it

What has FDA decided for it lately?

  • K251298Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2…Clinical Laserthermia Systems, AB · 2025
  • K214125TRANBERG Thermoguide Therapy SystemClinical Laserthermia Systems, AB · 2022
  • K201466Tranberg CLS Laser ApplicatorClinical Laserthermia Systems, AB · 2021
  • K163103Tranberg CLS Diffusor Laser FiberClinical Laserthermia Systems, AB · 20171 recall
  • K151569Tranberg CLS Laser FiberClinical Laserthermia Systems, AB · 20161 recall
  • K142216Tranberg CLS Thermal Therapy SystemClinical Laserthermia Systems, AB · 2015

All 6 as Clinical Laserthermia Systems, AB →

What has been recalled?

1 recall linked to its devices; the latest:

  • K151569Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02…Apr 1, 2021Class II