510(k) · Cleared
ClearedCellFX System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulse Biosciences, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 25, 2021 as substantially equivalent to K203299 (Pulse Biosciences, Inc., 2021) after a 107-day review. Its family tree reaches back 18 generations to 1995. 3 later devices descend from it.
- Decided
- Aug 25, 2021
- Review
- 107 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K943450 (1995). 226 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 3 citing it directly.
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations between
- 3 generations backK073572 Matrix RF ApplicatorSyneron Medical, Ltd. · 2008
- 2 generations backK102461 FractoraInvasix, Ltd. · 2011
- 1 generation backK203299 CellFX SystemPulse Biosciences, Inc. · 2021
- This deviceK211444 CellFX SystemPulse Biosciences, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK213674 CellFX SystemPulse Biosciences, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK222075 CellFX SystemPulse Biosciences, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK221671 CellFX® SystemPulse Biosciences, Inc. · 2022
Show all 18 generations
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 14 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 13 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 12 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 11 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 10 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK032088 Modification to Thermacool TC SystemThermage, Inc. · 2003
- 7 generations backK052778 Thermage Thermacool Skin MarketingThermage, Inc. · 2005
- 6 generations backK060948 Portrait PSR3Rhytec Incorporated · 2006 · Recalled
- 5 generations backK071786 Portrait PSRRhytec Incorporated · 2007
- 4 generations backK072394 Portrait Stand-OffRhytec Incorporated · 2007
- 3 generations backK073572 Matrix RF ApplicatorSyneron Medical, Ltd. · 2008
- 2 generations backK102461 FractoraInvasix, Ltd. · 2011
- 1 generation backK203299 CellFX SystemPulse Biosciences, Inc. · 2021
- This deviceK211444 CellFX SystemPulse Biosciences, Inc. · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −17 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −14 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −13 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −12 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −11 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −10 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K032088 | Modification to Thermacool TC System | Thermage, Inc. | 2003 | — |
| −7 | K052778 | Thermage Thermacool Skin Marketing | Thermage, Inc. | 2005 | — |
| −6 | K060948 | Portrait PSR3 | Rhytec Incorporated | 2006 | 1 |
| −5 | K071786 | Portrait PSR | Rhytec Incorporated | 2007 | — |
| −4 | K072394 | Portrait Stand-Off | Rhytec Incorporated | 2007 | — |
| −3 | K073572 | Matrix RF Applicator | Syneron Medical, Ltd. | 2008 | — |
| −2 | K102461 | Fractora | Invasix, Ltd. | 2011 | — |
| −1 | K203299 | CellFX System | Pulse Biosciences, Inc. | 2021 | — |
| 0 (this device) | K211444 | CellFX System | Pulse Biosciences, Inc. | 2021 | — |
| +1 | K213674 | CellFX System | Pulse Biosciences, Inc. | 2022 | — |
| +1 | K222075 | CellFX System | Pulse Biosciences, Inc. | 2022 | — |
| +1 | K221671 | CellFX® System | Pulse Biosciences, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 15 | 0 |
| 1995 | 13 | 0 |
| 1996 | 18 | 0 |
| 1997 | 14 | 0 |
| 1998 | 12 | 0 |
| 1999 | 10 | 0 |
| 2000 | 19 | 0 |
| 2001 | 20 | 0 |
| 2002 | 25 | 0 |
| 2003 | 20 | 0 |
| 2004 | 10 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 3 | 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? (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 |
|---|---|---|---|
| * | K203299 | CellFX SystemSummary page 4…Regulation Class: Class II Product Code: GEI Classification Panel: General and Plastic Surgery III. PREDICATE DEVICE K203299 – CellFX® System, Pulse Biosciences, Inc. No reference devices were used in this submission. IV. DEVICE DESCRIPTION… | 2021 |
What descends from it? (3)
3 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?
- The line of descent spans 26 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 10 of the 226 ancestors have a recall of any class.
- Of its descendants, K213674 (Pulse Biosciences, Inc., 2022) 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. 2021, 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 CellFX® System is intended for dermatological procedures requiring ablation and resurfacing of the skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211444 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211444: CellFX System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211444
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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