Clinical Laserthermia Systems, AB: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Clinical Laserthermia Systems, AB” (first 2015, latest 2025), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 250 days. Since 2017 the median was 201 days, against 90 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 1 | 252 |
| 2016 | 1 | 247 |
| 2017 | 1 | 136 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 297 |
| 2022 | 1 | 266 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 129 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Clinical Laserthermia Systems, AB took a median 201 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 4 | 4 |
| ONO | Neurosurgical Laser With Mr Thermography | 2 | 2 |
Review panels
Most recent Clinical Laserthermia Systems, AB 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251298 | Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6) | ONO | 2025-09-04 | 129 |
| K214125 | TRANBERG Thermoguide Therapy System | ONO | 2022-09-22 | 266 |
| K201466 | Tranberg CLS Laser Applicator | GEX | 2021-03-26 | 297 |
| K163103 | Tranberg CLS Diffusor Laser Fiber | GEX | 2017-03-23 | 136 |
| K151569 | Tranberg CLS Laser Fiber | GEX | 2016-02-12 | 247 |
| K142216 | Tranberg CLS Thermal Therapy System | GEX | 2015-04-21 | 252 |
Recalls
3 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2021-04-01.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Clinical Laserthermia Systems, AB is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05296122: Safety and Feasibility of MR-guided Laser Thermal Ablation of Brain Lesions (Completed, started 2022-05-12)
- NCT02973217: Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer (Completed, started 2016-10)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Clinical Data, Inc. (37 510(k)s)
- Clinical Sciences, Inc. (30 510(k)s)
- Clinical Assays, Inc. (27 510(k)s)
- Clinical Controls, Inc. (18 510(k)s)
- Clinical Innovations, LLC (18 510(k)s)
- Clinical Resources, Inc. (14 510(k)s)
- Clinical Technology Corp. (12 510(k)s)
- Clinical Connections, Inc. (10 510(k)s)
- Clinical Diagnostics, Inc. (8 510(k)s)
- Clinical Convenience Products, Inc. (6 510(k)s)
- Clinical Neuro Systems, LLC (5 510(k)s)
- Clinical Bioresearch (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Clinical Laserthermia Systems, AB?
FDA lists 6 510(k) clearances under the applicant name “Clinical Laserthermia Systems, AB” (first 2015, latest 2025), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Clinical Laserthermia Systems, AB?
The median time from FDA receipt to decision across 510(k)s cleared under the name Clinical Laserthermia Systems, AB is 250 days. Since 2017: 201 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Clinical Laserthermia Systems, AB?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 4); ONO (Neurosurgical Laser With Mr Thermography, 2).
Next steps
- See all 6 Clinical Laserthermia Systems, AB clearances with predicates and recalls
- Run predicate analysis for product code GEX, Clinical Laserthermia Systems, AB's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.