510(k) · Cleared
ClearedAtrilaze Laser 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 Aug 8, 2008 as substantially equivalent to K060680 (Medical Cv, Inc., 2006) after a 77-day review. Its family tree reaches back 5 generations to 1998. 1 later device descends from it.
- Decided
- Aug 8, 2008
- Review
- 77 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K980668 (1998). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK980668 CMS Blizzard 700 Series Models 730, 740,750,760,770,780 & 790Cryomedical Sciences, Inc. · 1998
- 4 generations backK011988 Surgical Lightstic 180, Model 180 L, Model 180 CCardiofocus, Inc. · 2001
- 3 generations backK013901 Malleable Surgical Lightstic 180, Model 180 (1CM-9CM)Cardiofocus, Inc. · 2001
- 2 generations backK052495 Atrilaze Malleable Ablation ProbeMedical Cv, Inc. · 2005
- 1 generation backK060680 Atrilaze Surgical Ablation SystemMedical Cv, Inc. · 2006
- This deviceK081457 Atrilaze Laser Ablation SystemMedical Cv, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK082409 Solar Laser Ablation System, Models: LU-1083-25, LF-1083, PC-1000…Endophotonix, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K082409Solar Laser Ablation System, Models: LU-1083-25, LF-1083, PC-1000, IC-1083, LW-2000…Endophotonix, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K980668 | CMS Blizzard 700 Series Models 730, 740,750,760,770,780 & 790 | Cryomedical Sciences, Inc. | 1998 | — |
| −4 | K011988 | Surgical Lightstic 180, Model 180 L, Model 180 C | Cardiofocus, Inc. | 2001 | — |
| −3 | K013901 | Malleable Surgical Lightstic 180, Model 180 (1CM-9CM) | Cardiofocus, Inc. | 2001 | — |
| −2 | K052495 | Atrilaze Malleable Ablation Probe | Medical Cv, Inc. | 2005 | — |
| −1 | K060680 | Atrilaze Surgical Ablation System | Medical Cv, Inc. | 2006 | — |
| 0 (this device) | K081457 | Atrilaze Laser Ablation System | Medical Cv, Inc. | 2008 | — |
| +1 | K082409 | Solar Laser Ablation System, Models: LU-1083-25, LF-1083, PC-1000, IC-1083… | Endophotonix, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K060680 | Atrilaze Surgical Ablation SystemSummary page 2…complications may be serious. Technological Comparison: The ATRILAZETM Surgical Ablation System was compared to the current ATRILAZETM Surgical Ablation System (K060680). Both the currently available device and the ATRILAZETM wand as reviewed in this 510(k) are provided sterile with a ste… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082409 | Solar Laser Ablation System, Models: LU-1083-25, LF-1083, PC-1000, IC-1083, LW-2000… | 2009 | 0 |
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 10 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K082409 (Endophotonix, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K060680.
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 ATRILAZE Surgical Ablation System is indicated for delivery of 810nm, 1064nm or 1083nm 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.
The ATRILAZE Surgical Ablation System Accessories are intended for use in the support of the delivery of laser light to soft tissue to include cardiac tissue during surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081457 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081457: Atrilaze Laser Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081457
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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