510(k) · Cleared
ClearedRhytec, Inc., Portrait PSR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rhytec Incorporated · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Aug 22, 2008 as substantially equivalent to K073111 (Rhytec Incorporated, 2008) after an 18-day review. Its family tree reaches back 15 generations to 1995. 3 later devices descend from it.
- Decided
- Aug 22, 2008
- Review
- 18 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K943450 (1995). 147 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations between
- 3 generations backK060948 Portrait PSR3Rhytec Incorporated · 2006 · Recalled
- 2 generations backK071786 Portrait PSRRhytec Incorporated · 2007
- 1 generation backK073111 Portrait PSR, Model 745915Rhytec Incorporated · 2008
- This deviceK082197 Rhytec, Inc., Portrait PSRRhytec Incorporated · 2008
- Descendant · cites it directly · 2 of its ownK132754 Neogen PSR SystemEnergist, Ltd. · 2013
- Descendant · 2 generations on · 0 of its ownK221873 NeoGen PSR SystemEnergist Limited · 2023
- Descendant · 2 generations on · 0 of its ownK211652 Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation · 2022
Show all 15 generations
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 10 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 9 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 8 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 7 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 5 generations backK032088 Modification to Thermacool TC SystemThermage, Inc. · 2003
- 4 generations backK052778 Thermage Thermacool Skin MarketingThermage, Inc. · 2005
- 3 generations backK060948 Portrait PSR3Rhytec Incorporated · 2006 · Recalled
- 2 generations backK071786 Portrait PSRRhytec Incorporated · 2007
- 1 generation backK073111 Portrait PSR, Model 745915Rhytec Incorporated · 2008
- This deviceK082197 Rhytec, Inc., Portrait PSRRhytec Incorporated · 2008
Most influential descendants
Showing 3 of 3 · See all- K132754Neogen PSR SystemEnergist, Ltd. · 2013 · cites it directly2descendants
- K221873NeoGen PSR SystemEnergist Limited · 2023 · 2 generations on0descendants
- K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −14 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −10 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −9 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −8 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −7 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −5 | K032088 | Modification to Thermacool TC System | Thermage, Inc. | 2003 | — |
| −4 | K052778 | Thermage Thermacool Skin Marketing | Thermage, Inc. | 2005 | — |
| −3 | K060948 | Portrait PSR3 | Rhytec Incorporated | 2006 | 1 |
| −2 | K071786 | Portrait PSR | Rhytec Incorporated | 2007 | — |
| −1 | K073111 | Portrait PSR, Model 745915 | Rhytec Incorporated | 2008 | — |
| 0 (this device) | K082197 | Rhytec, Inc., Portrait PSR | Rhytec Incorporated | 2008 | — |
| +1 | K132754 | Neogen PSR System | Energist, Ltd. | 2013 | — |
| +2 | K221873 | NeoGen PSR System | Energist Limited | 2023 | — |
| +2 | K211652 | Renuvion Dermal Handpiece, Renuvion Dermal System | Apyx Medical Corporation (Formerly Bovie Medical Corporation | 2022 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2022 | 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 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 |
|---|---|---|---|
| * | K073111 | Portrait PSR, Model 745915Summary page 1…Portrait® PSR 3 System Classification Name: Electrosurgical cutting and coagulation device Product Code: GEl Legally Market Predicate Devices K073111 Portrait® PSR3 System Device Description The Portrait® PSR3 System is an electro-surgical device for use in dermatological appli… | 2008 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132754 | Neogen PSR System | 2013 | 2 |
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 13 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 8 of the 147 ancestors have a recall of any class.
- Of its descendants, K132754 (Energist, Ltd., 2013) has gone furthest, with 2 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. 2008, 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 Portrait® PSR 3 System is indicated for treatment of the following dermatological conditions:
• Treatment of wrinkles and rhytides
• Superficial skin lesions
• Actinic keratosis
• Viral papillomata
• Seborrhoeic keratosis
• Acne scars
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082197 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082197: Rhytec, Inc., Portrait PSR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082197
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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