510(k) · Cleared
ClearedATOVEN-Reusable Laser Fiber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diotech CO · GEX Powered Laser Surgical Instrument
Cleared on Jun 9, 2016 as substantially equivalent to K140458 (Diotech CO, 2014) and 1 other predicate after a 266-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Jun 9, 2016
- Review
- 266 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K904627 (1991). 38 ancestors in all, the oldest K812219 (1981). No later device cites it as a predicate yet.
- Root · 4 generations backK904627 Centauri Yag Laser Syst, Ear, Nose , ThroatPfizer Laser Systems · 1991
- 3 generations backK960032 Coherent Versapulse Aesthetic Surgical LasersCoherent Medical Group · 1996
- 2 generations backK050738 FT Fiber Optic Delivery SystemsFibertech GmbH · 2005 · Recalled
- 1 generation backK140366 Endlessfiber Reusable Surgical Laser FiberHogue Surgical, LLC · 2014
- This deviceK152667 ATOVEN-Reusable Laser FiberDiotech CO · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K904627 | Centauri Yag Laser Syst, Ear, Nose , Throat | Pfizer Laser Systems | 1991 | — |
| −3 | K960032 | Coherent Versapulse Aesthetic Surgical Lasers | Coherent Medical Group | 1996 | — |
| −2 | K050738 | FT Fiber Optic Delivery Systems | Fibertech GmbH | 2005 | 5 |
| −1 | K140366 | Endlessfiber Reusable Surgical Laser Fiber | Hogue Surgical, LLC | 2014 | — |
| 0 (this device) | K152667 | ATOVEN-Reusable Laser Fiber | Diotech CO | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 9 | 0 |
| 1995 | 5 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 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? (2)
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 |
|---|---|---|---|
| * | K140458 | Diotech Laser FiberSummary page 4…logy 4) Product code : GEX 5) Regulation number : 878.4810 6) Class of device : Class II 3. The legally marketed device to which we are claiming equivalence K140458, K140366 4. Description of device ATOVEN-Reusable Laser Fiber is free-beam delivery device that transits laser energy into… | 2014 |
| * | K140366 | Endlessfiber Reusable Surgical Laser FiberSummary page 4…) Product code : GEX 5) Regulation number : 878.4810 6) Class of device : Class II 3. The legally marketed device to which we are claiming equivalence K140458, K140366 4. Description of device ATOVEN-Reusable Laser Fiber is free-beam delivery device that transits laser energy into intended… | 2014 |
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 5 companies; a new generation was cleared every 9.2 years on median.
- 2 of the 38 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. 2016, 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?
ATOVEN-Reusable Laser Fiber is indicated for endovascular coagulation of the great saphenous vein in
patients with superficial vein reflux. for the treatment of varicose veins and varicosities associated with
superficial reflux of the great saphenous vein, and for the treatment of incompetence and reflux
of superficial veins of the lower extremity.
The ATOVEN-Reusable Laser Fiber may be used with CW laser with wavelength range 810-1470 nm, a power
range 5-15W, using an SMA905 connector.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152667 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152667: ATOVEN-Reusable Laser Fiber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152667
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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