510(k) · Cleared
ClearedPlasmajet Neutral Plasma Surgery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plasma Surgical Limited · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 20, 2012 as substantially equivalent to K080197 (Plasma Surgical, Ltd., 2008) and 2 other predicates after a 138-day review. Its family tree reaches back 8 generations to 1994. 1 later device descends from it.
- Decided
- Nov 20, 2012
- Review
- 138 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K936109 (1994). 33 ancestors in all, the oldest K822136 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 7 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 6 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 5 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 4 generations backK022060 Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and…Lumenis, Inc. · 2002
- 3 generations backK030147 Lumenis Family of Ultrapulse Surgitouch CO2 Surgical LasersLumenis, Ltd. · 2003
- 2 generations backK082809 Acupulse 30 and 40 Carbon Dioxide Laser SystemLumenis, Inc. · 2008
- 1 generation backK100415 Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser SystemLumenis · 2010 · Recalled
- This deviceK121977 Plasmajet Neutral Plasma Surgery SystemPlasma Surgical Limited · 2012
- Descendant · cites it directly · 0 of its ownK253917 ARION ARC SystemPlasma Surgical, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253917ARION ARC SystemPlasma Surgical, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −7 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −6 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −5 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −4 | K022060 | Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device… | Lumenis, Inc. | 2002 | — |
| −3 | K030147 | Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers | Lumenis, Ltd. | 2003 | — |
| −2 | K082809 | Acupulse 30 and 40 Carbon Dioxide Laser System | Lumenis, Inc. | 2008 | — |
| −1 | K100415 | Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser System | Lumenis | 2010 | 1 |
| 0 (this device) | K121977 | Plasmajet Neutral Plasma Surgery System | Plasma Surgical Limited | 2012 | — |
| +1 | K253917 | ARION ARC System | Plasma Surgical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K080197 | Plasmajet Neutral Plasma Surgery SystemSummary page 1…roduct Code GEL 3 Predicate Devices The components of the PlasmaJet® system are substantially equivalent to the following legally marketed devices:. K080197 Plasma Surgical Plasmaiet® Neutral Plasma Surgery System K031085 Gyrus PlasmaKinetic Superpulse Ge… | 2008 |
| * | K031085 | Gyrus Plasmakinetic Superpulse System (Generator, Accessories)Summary page 1…tantially equivalent to the following legally marketed devices:. K080197 Plasma Surgical Plasmaiet® Neutral Plasma Surgery System K031085 Gyrus PlasmaKinetic Superpulse Generator System & Accessories K100415 Lumenis AcuPulse 30/40ST an… | 2003 |
| * | K100415 | Acupulse 30/40 ST CO2 Laser System and Acupulse 40WG CO2 Laser SystemSummary page 1…Plasma Surgical Plasmaiet® Neutral Plasma Surgery System K031085 Gyrus PlasmaKinetic Superpulse Generator System & Accessories K100415 Lumenis AcuPulse 30/40ST and 4OWG C02 Laser Systemns… | 2010 |
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 |
|---|---|---|---|
| K253917 | ARION ARC System | 2026 | 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 18 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 33 ancestors have a recall of any class.
- Of its descendants, K253917 (Plasma Surgical, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The PlasmaJet is a neutral plasma surgery system that is designed for cutting, coagulation and the removal of soft tissue by vaporization in open surgery and laparoscopic surgery.
The PlasmaJet is a neutral plasma surgery system that is designed for cutting, coagulation and the removal of soft tissue by vaporization in open surgery and laparoscopic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121977 · printed Nov 4, 2026
Cite this page
510(k) Report. “K121977: Plasmajet Neutral Plasma Surgery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K121977
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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