510(k) · Cleared
ClearedLightscalpel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lightscalpel, LLC · GEX Powered Laser Surgical Instrument
Cleared on Nov 29, 2012 as substantially equivalent to K953074 (Luxar Corp., 1995) and 1 other predicate after a 62-day review. Its family tree reaches back 1 generation to 1995. 4 later devices descend from it.
- Decided
- Nov 29, 2012
- Review
- 62 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K953074 (1995). 2 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK953074 Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp. · 1995
- This deviceK123037 LightscalpelLightscalpel, LLC · 2012
- Descendant · cites it directly · 3 of its ownK132661 LightscalpelLightscalpel, LLC · 2014
- Descendant · cites it directly · 2 of its ownK141658 Light ScalpelLightscalpel, LLC · 2014
- Descendant · 2 generations on · 0 of its ownK213669 Lightscalpel LS-4020Lightscalpel, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK173827 LightScalpelLightscalpel, LLC · 2018
Most influential descendants
Showing 4 of 4 · See all- K132661LightscalpelLightscalpel, LLC · 2014 · cites it directly3descendants
- K141658Light ScalpelLightscalpel, LLC · 2014 · cites it directly2descendants
- K213669Lightscalpel LS-4020Lightscalpel, Inc. · 2023 · 2 generations on0descendants
- K173827LightScalpelLightscalpel, LLC · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K953074 | Modified Luxar LX-20 Family CO2 Laser System | Luxar Corp. | 1995 | — |
| 0 (this device) | K123037 | Lightscalpel | Lightscalpel, LLC | 2012 | — |
| +1 | K132661 | Lightscalpel | Lightscalpel, LLC | 2014 | — |
| +1 | K141658 | Light Scalpel | Lightscalpel, LLC | 2014 | — |
| +2 | K213669 | Lightscalpel LS-4020 | Lightscalpel, Inc. | 2023 | — |
| +2 | K173827 | LightScalpel | Lightscalpel, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K953074 | Modified Luxar LX-20 Family CO2 Laser SystemSummary page 3…e following table. Characteristic LightScalpel Luxar LX-20 SP DEKA Smartide Predicate 510(k) N/A K953074 K072159 Laser Medium C0 2 C02 C0 2 Wavelength (pm)… | 1995 |
| * | K072159 | Smart CO2 (Smartxide, Smart US20D) with Dot ScannerSummary page 3…Characteristic LightScalpel Luxar LX-20 SP DEKA Smartide Predicate 510(k) N/A K953074 K072159 Laser Medium C0 2 C02 C0 2 Wavelength (pm) 1… | 2007 |
What descends from it? (4)
2 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. 2012, 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 LightScalpel LS-10 CO2 Laser System is intended for use in laser surgery procedures for incision, excision, vaporization, ablation, or coagulation of soft tissue in specialties such as: general surgery, dermatology, gynecology, oral surgery, otorhinolaryngology, plastic & reconstructive surgery, podiatry, and urology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123037 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123037: Lightscalpel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123037
Report an extraction error
Are you the manufacturer?
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