510(k) · Cleared
ClearedTranberg CLS Laser Applicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clinical Laserthermia Systems, AB · GEX Powered Laser Surgical Instrument
Cleared on Mar 26, 2021 as substantially equivalent to K163103 (Clinical Laserthermia Systems, AB, 2017) after a 297-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Mar 26, 2021
- Review
- 297 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K963081 (1997). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK963081 Indigo Medical Model Idl 830 & Model Idl 830E Laser Systems for…Indigo Medical, Inc. · 1997
- 3 generations backK053087 Visualase Cooled Laser Applicator System, Laser Diffusing Fiber…Biotex, Inc. · 2006 · Recalled
- 2 generations backK151569 Tranberg CLS Laser FiberClinical Laserthermia Systems, AB · 2016 · Recalled
- 1 generation backK163103 Tranberg CLS Diffusor Laser FiberClinical Laserthermia Systems, AB · 2017 · Recalled
- This deviceK201466 Tranberg CLS Laser ApplicatorClinical Laserthermia Systems, AB · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K963081 | Indigo Medical Model Idl 830 & Model Idl 830E Laser Systems for General… | Indigo Medical, Inc. | 1997 | — |
| −3 | K053087 | Visualase Cooled Laser Applicator System, Laser Diffusing Fiber, Cooling… | Biotex, Inc. | 2006 | 5 |
| −2 | K151569 | Tranberg CLS Laser Fiber | Clinical Laserthermia Systems, AB | 2016 | 1 |
| −1 | K163103 | Tranberg CLS Diffusor Laser Fiber | Clinical Laserthermia Systems, AB | 2017 | 1 |
| 0 (this device) | K201466 | Tranberg CLS Laser Applicator | Clinical Laserthermia Systems, AB | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K163103 | Tranberg CLS Diffusor Laser FiberSummary page 4…l Instrument Review Panel General and Plastic Surgery PREDICATE DEVICE: K163103, Clinical LaserThermia Systems Tranberg® Laser Diffuser Fiber I… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
- 3 of the 5 ancestors have a recall of any class.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The TRANBERGCLS| Laser Applicator is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology, and urology, for wavelengths 980nm through 1064nm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201466 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201466: Tranberg CLS Laser Applicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201466
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026