510(k) · Cleared
ClearedFox 940, Model 940
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Valam, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Feb 22, 2008 as substantially equivalent to K062619 (CAO Group, Inc., 2006) and 1 other predicate after a 228-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Feb 22, 2008
- Review
- 228 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K011041 (2001). 12 ancestors in all, the oldest K952661 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK011041 Waterlase, MillenniumBiolase Technology, Inc. · 2001
- 3 generations backK030539 LasersmileBiolase Technology, Inc. · 2003
- 2 generations backK050453 Odyssey 2.4G, Denlaser Elite, Model 002-00050Ivoclar Vivadent, Inc. · 2005
- 1 generation backK062619 Denlaser 800 PlusCAO Group, Inc. · 2006
- This deviceK071896 Fox 940, Model 940Valam, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011041 | Waterlase, Millennium | Biolase Technology, Inc. | 2001 | — |
| −3 | K030539 | Lasersmile | Biolase Technology, Inc. | 2003 | — |
| −2 | K050453 | Odyssey 2.4G, Denlaser Elite, Model 002-00050 | Ivoclar Vivadent, Inc. | 2005 | — |
| −1 | K062619 | Denlaser 800 Plus | CAO Group, Inc. | 2006 | — |
| 0 (this device) | K071896 | Fox 940, Model 940 | Valam, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 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 |
|---|---|---|---|
| * | K062619 | Denlaser 800 PlusSummary page 1…Trade Name: Fox 940 Laser Device Common Name: Diode Laser Classification Name: Laser Surgical Instrument Predicate Devices: Fox 81 0 (K062619), LaserPro (K040924) Device Description: Fox 940 is a diode laser with 940 nM wavelength and ma… | 2006 |
| * | K040294 | Laserpro Diode Laser Systems, Models 810, 940 & 980 Our reading of the summary gave K040924, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “LaserPro”. | 2004 |
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 7 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 12 ancestors has a recall of any class.
- 4 other devices also cite its predicate K062619.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Fox 940 Diode Laser is indicated for:
Surgical applications requiring the ablation, vaporization, excision, incision, hemostasis,
or coagulation of soft tissues in medical specialties including dermatology,
gastroenterology, general surgery, genitourinary, gynecology, neurosurgery,
otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071896 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071896: Fox 940, Model 940.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071896
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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