510(k) · Cleared
ClearedWolf445nm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A.R.C Laser GmbH · GEX Powered Laser Surgical Instrument
Cleared on Mar 17, 2020 as substantially equivalent to K951034 (Laserscope, 1995) after a 208-day review. Its family tree reaches back 1 generation to 1995. 6 later devices descend from it.
- Decided
- Mar 17, 2020
- Review
- 208 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951034 (1995). 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK951034 Aura Laser SystemLaserscope · 1995
- This deviceK192272 Wolf445nmA.R.C Laser GmbH · 2020
- Descendant · cites it directly · 3 of its ownK202991 Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021
- Descendant · 2 generations on · 1 of its ownK221712 Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm…Fotona D.O.O. · 2022
- Descendant · cites it directly · 0 of its ownK243683 Deka BluebeamEl.En S.P.A. · 2025
- Descendant · 3 generations on · 0 of its ownK232885 Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd · 2024
- Descendant · 2 generations on · 0 of its ownK220531 Fox 810, Fox 980A.R.C Laser GmbH · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K202991Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021 · cites it directly3descendants
- K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O. · 2022 · 2 generations on1descendant
- K243683Deka BluebeamEl.En S.P.A. · 2025 · cites it directly0descendants
- K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd · 2024 · 3 generations on0descendants
- K220531Fox 810, Fox 980A.R.C Laser GmbH · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951034 | Aura Laser System | Laserscope | 1995 | — |
| 0 (this device) | K192272 | Wolf445nm | A.R.C Laser GmbH | 2020 | — |
| +1 | K202991 | Fotona XPulse Pro Laser Platform | Fotona D.O.O. | 2021 | — |
| +2 | K221712 | Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) | Fotona D.O.O. | 2022 | — |
| +1 | K243683 | Deka Bluebeam | El.En S.P.A. | 2025 | — |
| +3 | K232885 | Dawn Diode Laser System | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | 2024 | — |
| +2 | K220531 | Fox 810, Fox 980 | A.R.C Laser GmbH | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K951034 | Aura Laser SystemSummary page 4…urgery and in dermatology Device product code: GEX Device Classification 21 CFR 878.4810 Predicate Devices: Aura Laser System, K951034, Primary Predicate SiroLaser Blue, K180044, Reference Predicate Device Description: The Wolf Diode Lasers are a… | 1995 |
| † | K180044 | SIROLaser Blue | 2018 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 Wolf 445nm is intended for incision, excision, vaporization, ablation, hemostasis and coagulation of soft tissue.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K192272 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192272: Wolf445nm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K192272
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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