510(k) · Cleared
ClearedAvenda Health Treatment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avenda Health, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Nov 30, 2020 as substantially equivalent to K142216 (Clinical Laserthermia Systems, AB, 2015) after a 161-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Nov 30, 2020
- Review
- 161 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K952661 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK952661 SLT Thermalite Diode Laser Series, Diode 980, 810, 940Surgical Laser Technologies, Inc. · 1995
- 3 generations backK060304 Photex Diode Laser Series, Models 980, 810 and 940Biotex, Inc. · 2006
- 2 generations backK092197 PHOTEX30 Diode Laser Series: 980, 810, 940Biotex, Inc. · 2009
- 1 generation backK142216 Tranberg CLS Thermal Therapy SystemClinical Laserthermia Systems, AB · 2015
- This deviceK201687 Avenda Health Treatment SystemAvenda Health, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K952661 | SLT Thermalite Diode Laser Series, Diode 980, 810, 940 | Surgical Laser Technologies, Inc. | 1995 | — |
| −3 | K060304 | Photex Diode Laser Series, Models 980, 810 and 940 | Biotex, Inc. | 2006 | — |
| −2 | K092197 | PHOTEX30 Diode Laser Series: 980, 810, 940 | Biotex, Inc. | 2009 | — |
| −1 | K142216 | Tranberg CLS Thermal Therapy System | Clinical Laserthermia Systems, AB | 2015 | — |
| 0 (this device) | K201687 | Avenda Health Treatment System | Avenda Health, Inc. | 2020 | — |
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 |
|---|---|---|---|
| * | K142216 | Tranberg CLS Thermal Therapy SystemSummary page 5…PREMARKET NOTIFICATION (K201687) 510(k) SUMMARY PREDICATE DEVICE [807.92(a)(3)] Predicate Device: Clinical Laserthermia Systems AB TranbergCLS Thermal Therapy System (K142216) Reference Predicate Device: Medtronic Navigation Inc. Visualase Thermal Therapy System (K181859) DEVICE DESCRIPTION [807.92(a)(… | 2015 |
| † | K181859 | Visualase Thermal Therapy System | 2019 |
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 25 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 Avenda Health Treatment System is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in areas of surgery including: cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardia! sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, at a wavelength of 980nm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201687 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201687: Avenda Health Treatment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201687
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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