Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Clinical Laserthermia Systems, AB · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
252 daysmedian FDA review time
297 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251298 | Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N | Clinical Laserthermia Systems, AB | 2025-09-04 | 129 | 0 |
| K214125 | TRANBERG Thermoguide Therapy System | Clinical Laserthermia Systems, AB | 2022-09-22 | 266 | 0 |
| K201466 | Tranberg CLS Laser Applicator | Clinical Laserthermia Systems, AB | 2021-03-26 | 297 | 0 |
| K163103 | Tranberg CLS Diffusor Laser Fiber | Clinical Laserthermia Systems, AB | 2017-03-23 | 136 | 0 |
| K151569 | Tranberg CLS Laser Fiber | Clinical Laserthermia Systems, AB | 2016-02-12 | 247 | 0 |
| K142216 | Tranberg CLS Thermal Therapy System | Clinical Laserthermia Systems, AB | 2015-04-21 | 252 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda