510(k) · Cleared
ClearedAtrilaze Soft Tissue Ablation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Cv, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Nov 30, 2004 as substantially equivalent to K001975 (Ceram Optec, Inc., 2000) and 1 other predicate after a 252-day review. Its family tree reaches back 2 generations to 2000. 5 later devices descend from it.
- Decided
- Nov 30, 2004
- Review
- 252 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K001975 (2000). 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK001975 Ceralas D10 810NM Laser, Model Ceralas D10-60Ceram Optec, Inc. · 2000
- 1 generation backK013201 Cardiofocus Diode Laser System, Models 60R, 60NR, 30NRCardiofocus, Inc. · 2002
- This deviceK040744 Atrilaze Soft Tissue Ablation SystemMedical Cv, Inc. · 2004
- Descendant · cites it directly · 4 of its ownK052495 Atrilaze Malleable Ablation ProbeMedical Cv, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK060680 Atrilaze Surgical Ablation SystemMedical Cv, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK081457 Atrilaze Laser Ablation SystemMedical Cv, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK061489 Atrilaze MI Surgical Ablation SystemMedical Cv, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK082409 Solar Laser Ablation System, Models: LU-1083-25, LF-1083, PC-1000…Endophotonix, Inc. · 2009
Most influential descendants
Showing 5 of 5 · See all- K052495Atrilaze Malleable Ablation ProbeMedical Cv, Inc. · 2005 · cites it directly4descendants
- K060680Atrilaze Surgical Ablation SystemMedical Cv, Inc. · 2006 · cites it directly3descendants
- K081457Atrilaze Laser Ablation SystemMedical Cv, Inc. · 2008 · 2 generations on1descendant
- K061489Atrilaze MI Surgical Ablation SystemMedical Cv, Inc. · 2007 · cites it directly1descendant
- K082409Solar Laser Ablation System, Models: LU-1083-25, LF-1083, PC-1000, IC-1083, LW-2000…Endophotonix, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001975 | Ceralas D10 810NM Laser, Model Ceralas D10-60 | Ceram Optec, Inc. | 2000 | — |
| −1 | K013201 | Cardiofocus Diode Laser System, Models 60R, 60NR, 30NR | Cardiofocus, Inc. | 2002 | — |
| 0 (this device) | K040744 | Atrilaze Soft Tissue Ablation System | Medical Cv, Inc. | 2004 | — |
| +1 | K052495 | Atrilaze Malleable Ablation Probe | Medical Cv, Inc. | 2005 | — |
| +1 | K060680 | Atrilaze Surgical Ablation System | Medical Cv, Inc. | 2006 | — |
| +2 | K081457 | Atrilaze Laser Ablation System | Medical Cv, Inc. | 2008 | — |
| +1 | K061489 | Atrilaze MI Surgical Ablation System | Medical Cv, Inc. | 2007 | — |
| +2 | K082409 | Solar Laser Ablation System, Models: LU-1083-25, LF-1083, PC-1000, IC-1083… | Endophotonix, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K001975 | Ceralas D10 810NM Laser, Model Ceralas D10-60Summary page 2…the Atrilaze Soft Tissue Ablation System was compared to the following predicate device(s): * Biolitec/Ceramoptec Ceralas DI0-25Fiber-coupled Diode Laser System (K001975) * CardioFocus Diode Laser System (K013201) Testing:: The results of biocompatibility testing support that the m… | 2000 |
| * | K013201 | Cardiofocus Diode Laser System, Models 60R, 60NR, 30NRSummary page 2…ared to the following predicate device(s): * Biolitec/Ceramoptec Ceralas DI0-25Fiber-coupled Diode Laser System (K001975) * CardioFocus Diode Laser System (K013201) Testing:: The results of biocompatibility testing support that the materials used in the manufacture of the Altrilaze… | 2002 |
What descends from it? (5)
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?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K052495 (Medical Cv, Inc., 2005) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K001975.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 MedicalCV, Inc. AtrilazeTM Soft Tissue Ablation System is indicated for delivery of 81Onm laser light to soft tissue to include cardiac tissue during surgical procedures. Indications include the incision, excision, dissection, vaporization, ablation, or 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/K040744 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040744: Atrilaze Soft Tissue Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040744
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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