510(k) · Cleared
ClearedPortrait PSR, Model 745915
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 Mar 27, 2008 as substantially equivalent to K071786 (Rhytec Incorporated, 2007) and 3 other predicates after a 143-day review. Its family tree reaches back 14 generations to 1995. 4 later devices descend from it.
- Decided
- Mar 27, 2008
- Review
- 143 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K943450 (1995). 146 ancestors in all, the oldest K800617 (1980). 4 later devices descend from it, 1 citing it directly.
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations between
- 3 generations backK052778 Thermage Thermacool Skin MarketingThermage, Inc. · 2005
- 2 generations backK060948 Portrait PSR3Rhytec Incorporated · 2006 · Recalled
- 1 generation backK071786 Portrait PSRRhytec Incorporated · 2007
- This deviceK073111 Portrait PSR, Model 745915Rhytec Incorporated · 2008
- Descendant · cites it directly · 3 of its ownK082197 Rhytec, Inc., Portrait PSRRhytec Incorporated · 2008
- Descendant · 2 generations on · 2 of its ownK132754 Neogen PSR SystemEnergist, Ltd. · 2013
- Descendant · 3 generations on · 0 of its ownK221873 NeoGen PSR SystemEnergist Limited · 2023
- Descendant · 3 generations on · 0 of its ownK211652 Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation · 2022
Show all 14 generations
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 10 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 9 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 8 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 7 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 6 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 5 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 4 generations backK032088 Modification to Thermacool TC SystemThermage, Inc. · 2003
- 3 generations backK052778 Thermage Thermacool Skin MarketingThermage, Inc. · 2005
- 2 generations backK060948 Portrait PSR3Rhytec Incorporated · 2006 · Recalled
- 1 generation backK071786 Portrait PSRRhytec Incorporated · 2007
- This deviceK073111 Portrait PSR, Model 745915Rhytec Incorporated · 2008
Most influential descendants
Showing 4 of 4 · See all- K082197Rhytec, Inc., Portrait PSRRhytec Incorporated · 2008 · cites it directly3descendants
- K132754Neogen PSR SystemEnergist, Ltd. · 2013 · 2 generations on2descendants
- K221873NeoGen PSR SystemEnergist Limited · 2023 · 3 generations on0descendants
- K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −13 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −10 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −9 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −8 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −7 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −6 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −5 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −4 | K032088 | Modification to Thermacool TC System | Thermage, Inc. | 2003 | — |
| −3 | K052778 | Thermage Thermacool Skin Marketing | Thermage, Inc. | 2005 | — |
| −2 | K060948 | Portrait PSR3 | Rhytec Incorporated | 2006 | 1 |
| −1 | K071786 | Portrait PSR | Rhytec Incorporated | 2007 | — |
| 0 (this device) | K073111 | Portrait PSR, Model 745915 | Rhytec Incorporated | 2008 | — |
| +1 | K082197 | Rhytec, Inc., Portrait PSR | Rhytec Incorporated | 2008 | — |
| +2 | K132754 | Neogen PSR System | Energist, Ltd. | 2013 | — |
| +3 | K221873 | NeoGen PSR System | Energist Limited | 2023 | — |
| +3 | 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 |
|---|---|---|
| 2008 | 1 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K071786 | Portrait PSRSummary page 1…(None) Classification Name: Electrosurgical cutting and coagulation device Product Code: GEl Legally Market Predicate Devices K071786 Portrait® PSR 3 K963339 Coherent UltraPulse K030453 CoolTouch ND:YAG K053047 Fraxel ISR Laser System Device Descrip… | 2007 |
| * | K963339 | Coherent Ultrapulse CO2 Surgical LasersSummary page 1…ation Name: Electrosurgical cutting and coagulation device Product Code: GEl Legally Market Predicate Devices K071786 Portrait® PSR 3 K963339 Coherent UltraPulse K030453 CoolTouch ND:YAG K053047 Fraxel ISR Laser System Device Description The Portrait® PSR 3 is… | 1997 |
| * | K030453 | Cooltouch ND: Yag Laser SystemSummary page 1…ical cutting and coagulation device Product Code: GEl Legally Market Predicate Devices K071786 Portrait® PSR 3 K963339 Coherent UltraPulse K030453 CoolTouch ND:YAG K053047 Fraxel ISR Laser System Device Description The Portrait® PSR 3 is an electro-surgical device for… | 2003 |
| * | K053047 | Fraxel SR Laser SystemSummary page 1…device Product Code: GEl Legally Market Predicate Devices K071786 Portrait® PSR 3 K963339 Coherent UltraPulse K030453 CoolTouch ND:YAG K053047 Fraxel ISR Laser System Device Description The Portrait® PSR 3 is an electro-surgical device for use in dermatological applica… | 2006 |
| † | K070284 | Fralex SR 1500 Laser System (Fralex II SR Laser System) | 2007 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082197 | Rhytec, Inc., Portrait PSR | 2008 | 3 |
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 146 ancestors have a recall of any class.
- Of its descendants, K082197 (Rhytec Incorporated, 2008) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K071786.
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 is intended for treatment of the following dermatological conductions:
1. Treatment of wrinkles and rhytides
2. Superficial skin lesions
3. Actinic keratosis
4. Viral papillomata
5. Seborrhoeic keratosis
6. Acne Scars
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073111 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073111: Portrait PSR, Model 745915.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073111
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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