510(k) · Cleared
ClearedAzuryt Model CLT 1401, CO2 Surgical Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diamond Age Systems, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Oct 7, 2004 as substantially equivalent to K031224 (Cynosure, Inc., 2003) and 4 other predicates after a 28-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Oct 7, 2004
- Review
- 28 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K953074 (1995). 5 ancestors in all, the oldest K896478 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK953074 Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp. · 1995
- 1 generation backK960475 Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp. · 1996
- This deviceK042439 Azuryt Model CLT 1401, CO2 Surgical Laser SystemDiamond Age Systems, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK062248 Azuryt Model CTL 1401, CO2 Surgical Laser SystemNorth American Clinical Lasers, Ltd. · 2006
Most influential descendants
Showing 1 of 1 · See all- K062248Azuryt Model CTL 1401, CO2 Surgical Laser SystemNorth American Clinical Lasers, Ltd. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953074 | Modified Luxar LX-20 Family CO2 Laser System | Luxar Corp. | 1995 | — |
| −1 | K960475 | Modified Luxar LX-20 Family CO2 Laser System | Luxar Corp. | 1996 | — |
| 0 (this device) | K042439 | Azuryt Model CLT 1401, CO2 Surgical Laser System | Diamond Age Systems, Inc. | 2004 | — |
| +1 | K062248 | Azuryt Model CTL 1401, CO2 Surgical Laser System | North American Clinical Lasers, Ltd. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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? (5)
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 |
|---|---|---|---|
| * | K031224 | SmartxideSummary page 1…The Azuryt Model CTL 1401, CO 2 Surgical Laser System is substantially equivalent to other laser systems on the market, such as the Deka Smart CO 2 laser, cleared under K031224 and K031440; and the Lumenis LX-20 CO 2 Surgical Laser System, cleared under K896478, K953074, and K960475. 4. Intended use… | 2003 |
| * | K031440 | Smart CO2 (Smart US 20D, Smart Clinic) Surgical LaserSummary page 1…Model CTL 1401, CO 2 Surgical Laser System is substantially equivalent to other laser systems on the market, such as the Deka Smart CO 2 laser, cleared under K031224 and K031440; and the Lumenis LX-20 CO 2 Surgical Laser System, cleared under K896478, K953074, and K960475. 4. Intended use of the devic… | 2003 |
| * | K896478 | Luxar Model LX-20 Minilase CO2 LaserSummary page 1…other laser systems on the market, such as the Deka Smart CO 2 laser, cleared under K031224 and K031440; and the Lumenis LX-20 CO 2 Surgical Laser System, cleared under K896478, K953074, and K960475. 4. Intended use of the device The Azuryt Model CTL 1401, C0 2 Surgical Laser System is indicated for… | 1990 |
| * | K953074 | Modified Luxar LX-20 Family CO2 Laser SystemSummary page 1…ser systems on the market, such as the Deka Smart CO 2 laser, cleared under K031224 and K031440; and the Lumenis LX-20 CO 2 Surgical Laser System, cleared under K896478, K953074, and K960475. 4. Intended use of the device The Azuryt Model CTL 1401, C0 2 Surgical Laser System is indicated for the inci… | 1995 |
| * | K960475 | Modified Luxar LX-20 Family CO2 Laser SystemSummary page 1…n the market, such as the Deka Smart CO 2 laser, cleared under K031224 and K031440; and the Lumenis LX-20 CO 2 Surgical Laser System, cleared under K896478, K953074, and K960475. 4. Intended use of the device The Azuryt Model CTL 1401, C0 2 Surgical Laser System is indicated for the incision, excisio… | 1996 |
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 |
|---|---|---|---|
| K062248 | Azuryt Model CTL 1401, CO2 Surgical Laser System | 2006 | 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 9 years and passes through 2 companies; a new generation was cleared every 8.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K062248 (North American Clinical Lasers, Ltd., 2006) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K031224.
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 Azuryt Model CTL 1401, CO 2 Surgical Laser System is indicated for the
incision, excision, ablation, vaporization and coagulation of body soft tissues,
including intraoral tissues. These systems can be used in a variety of medical
specialties, including general and plastic surgery, dentistry, oral/maxillofacial
surgery, dermatology, gastroenterology, gynecology, otorhinolaryngology,
aesthetical surgery, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic
surgery, and urology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042439 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042439: Azuryt Model CLT 1401, CO2 Surgical Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042439
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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