510(k) · Cleared
ClearedNeoGen PSR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Energist Limited · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 12, 2023 as substantially equivalent to K132754 (Energist, Ltd., 2013) and 1 other predicate after a 198-day review. Its family tree reaches back 17 generations to 1995.
- Decided
- Jan 12, 2023
- Review
- 198 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 17 generations to K943450 (1995). 150 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations between
- 3 generations backK073111 Portrait PSR, Model 745915Rhytec Incorporated · 2008
- 2 generations backK082197 Rhytec, Inc., Portrait PSRRhytec Incorporated · 2008
- 1 generation backK132754 Neogen PSR SystemEnergist, Ltd. · 2013
- This deviceK221873 NeoGen PSR SystemEnergist Limited · 2023
Show all 17 generations
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 13 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 12 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 11 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 10 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 9 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK032088 Modification to Thermacool TC SystemThermage, Inc. · 2003
- 6 generations backK052778 Thermage Thermacool Skin MarketingThermage, Inc. · 2005
- 5 generations backK060948 Portrait PSR3Rhytec Incorporated · 2006 · Recalled
- 4 generations backK071786 Portrait PSRRhytec Incorporated · 2007
- 3 generations backK073111 Portrait PSR, Model 745915Rhytec Incorporated · 2008
- 2 generations backK082197 Rhytec, Inc., Portrait PSRRhytec Incorporated · 2008
- 1 generation backK132754 Neogen PSR SystemEnergist, Ltd. · 2013
- This deviceK221873 NeoGen PSR SystemEnergist Limited · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −16 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −13 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −12 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −11 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −10 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −9 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K032088 | Modification to Thermacool TC System | Thermage, Inc. | 2003 | — |
| −6 | K052778 | Thermage Thermacool Skin Marketing | Thermage, Inc. | 2005 | — |
| −5 | K060948 | Portrait PSR3 | Rhytec Incorporated | 2006 | 1 |
| −4 | K071786 | Portrait PSR | Rhytec Incorporated | 2007 | — |
| −3 | K073111 | Portrait PSR, Model 745915 | Rhytec Incorporated | 2008 | — |
| −2 | K082197 | Rhytec, Inc., Portrait PSR | Rhytec Incorporated | 2008 | — |
| −1 | K132754 | Neogen PSR System | Energist, Ltd. | 2013 | — |
| 0 (this device) | K221873 | NeoGen PSR System | Energist Limited | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 15 | 0 |
| 1995 | 12 | 0 |
| 1996 | 17 | 0 |
| 1997 | 9 | 0 |
| 1998 | 9 | 0 |
| 1999 | 7 | 0 |
| 2000 | 11 | 0 |
| 2001 | 5 | 0 |
| 2002 | 14 | 0 |
| 2003 | 7 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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? (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 |
|---|---|---|---|
| * | K132754 | Neogen PSR SystemSummary page 5…tandoff, as well as 25mm. This is as per the Rhytec Portrait PSR3, which was the legally marketed predicate device cited when the NeoGen PSR was originally cleared under K132754. Handpiece usage is also monitored and the system limits use to guard against unexpected failure due to degradation with use over… | 2013 |
| * | K072394 | Portrait Stand-OffSummary page 11…imited NeoGen PSR 510(k) Application - 510(k) Summary TECHNOLOGY COMPARISON This is a review of the differences between the 25mm standoff arrangements as cleared in K072394 for use with the Rhytec PSR3, (the original predicate as cited in the K132754 submission for the NeoGen PSR), and those of the c… | 2007 |
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 28 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 8 of the 150 ancestors have a recall of any class.
- 1 other device also cites its predicate K132754.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
When used with the 5mm nozzle the NeoGen PSR System is intended for treatment of the following dermatological conditions:
• Treatment of wrinkles and rhytids
• Superficial skin lesions
• Actinic Keratosis
• Viral Papillomata
• Seborrheic Keratosis
• Acne Scars
When used with the 25mm nozzle, the NeoGen PSR System is intended for coagulation of tissue in dermatological procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221873 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221873: NeoGen PSR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221873
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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