510(k) · Cleared
ClearedSolar Laser Ablation System, Models: LU-1083-25, LF-1083, PC-1000, IC-1083, LW-2000, LG-2001, LK-001, PM-1083, TF-1083
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endophotonix, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jan 21, 2009 as substantially equivalent to K061489 (Medical Cv, Inc., 2007) and 1 other predicate after a 153-day review. Its family tree reaches back 6 generations to 1998.
- Decided
- Jan 21, 2009
- Review
- 153 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K980668 (1998). 21 ancestors in all, the oldest K811390 (1981). No later device cites it as a predicate yet.
- Root · 6 generations backK980668 CMS Blizzard 700 Series Models 730, 740,750,760,770,780 & 790Cryomedical Sciences, Inc. · 1998
- 5 generations backK011988 Surgical Lightstic 180, Model 180 L, Model 180 CCardiofocus, Inc. · 2001
- 4 generations backK013901 Malleable Surgical Lightstic 180, Model 180 (1CM-9CM)Cardiofocus, Inc. · 2001
- 3 generations backK052495 Atrilaze Malleable Ablation ProbeMedical Cv, Inc. · 2005
- 2 generations backK060680 Atrilaze Surgical Ablation SystemMedical Cv, Inc. · 2006
- 1 generation backK061489 Atrilaze MI Surgical Ablation SystemMedical Cv, Inc. · 2007
- This deviceK082409 Solar Laser Ablation System, Models: LU-1083-25, LF-1083, PC-1000…Endophotonix, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K980668 | CMS Blizzard 700 Series Models 730, 740,750,760,770,780 & 790 | Cryomedical Sciences, Inc. | 1998 | — |
| −5 | K011988 | Surgical Lightstic 180, Model 180 L, Model 180 C | Cardiofocus, Inc. | 2001 | — |
| −4 | K013901 | Malleable Surgical Lightstic 180, Model 180 (1CM-9CM) | Cardiofocus, Inc. | 2001 | — |
| −3 | K052495 | Atrilaze Malleable Ablation Probe | Medical Cv, Inc. | 2005 | — |
| −2 | K060680 | Atrilaze Surgical Ablation System | Medical Cv, Inc. | 2006 | — |
| −1 | K061489 | Atrilaze MI Surgical Ablation System | Medical Cv, Inc. | 2007 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K061489 | Atrilaze MI Surgical Ablation SystemSummary page 2…ogical Comparison: The SOLAR Surgical Ablation System was compared to the current ATRILAZE Surgical Ablation System (K081457) and SOLAR Surgical Ablation System (K061489) Both the currently available device and the SOLAR system as reviewed in this 510(k) are provided sterile with a sterile… | 2007 |
| * | K081457 | Atrilaze Laser Ablation SystemSummary page 2…d These complications may be serious Technological Comparison: The SOLAR Surgical Ablation System was compared to the current ATRILAZE Surgical Ablation System (K081457) and SOLAR Surgical Ablation System (K061489) Both the currently available device and the SOLAR system as reviewed in th… | 2008 |
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 11 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- None of the 21 ancestors has a recall.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 SOLAR TM Surgical Ablation System is indicated for delivery of 810nm, 1064nm, or
1083nm laser light to soft tissue, under visualization, during surgical procedures Indications
include the ablation, or coagulation of soft tissue
Warning:
The SOLAR TM Surgical Ablation System is not indicated fOr the treatment of cardiac
arrhythmias
The risk of actual damage to adjacent organs from the instrument exists and perforation,
rupture or tearing of tissue, may occur as a complication of laser use Burns can occur if the
laser energy is not correctly applied These complications may be serious
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082409 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082409: Solar Laser Ablation System, Models: LU-1083-25, LF-1083, PC-1000, IC-1083, LW-2000, LG-2001, LK-001, PM-1083, TF-1083.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082409
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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