510(k) · Cleared
ClearedPortrait Stand-Off
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 Sep 12, 2007 as substantially equivalent to K071786 (Rhytec Incorporated, 2007) after a 16-day review. Its family tree reaches back 14 generations to 1995. 104 later devices descend from it.
- Decided
- Sep 12, 2007
- Review
- 16 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K943450 (1995). 31 ancestors in all, the oldest K800617 (1980). 104 later devices descend from it, 2 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 deviceK072394 Portrait Stand-OffRhytec Incorporated · 2007
- Descendant · cites it directly · 102 of its ownK073572 Matrix RF ApplicatorSyneron Medical, Ltd. · 2008
- Descendant · 2 generations on · 64 of its ownK101510 Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd. · 2011
- Descendant · 3 generations on · 57 of its ownK130501 IntensifEndymed Medical, Ltd. · 2014
- Descendant · 4 generations on · 38 of its ownK180189 InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd. · 2018
- Descendant · 2 generations on · 24 of its ownK102461 FractoraInvasix, Ltd. · 2011
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 deviceK072394 Portrait Stand-OffRhytec Incorporated · 2007
Showing 5 of 104 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 104 · See all- K073572Matrix RF ApplicatorSyneron Medical, Ltd. · 2008 · cites it directly102descendants
- K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd. · 2011 · 2 generations on64descendants
- K130501IntensifEndymed Medical, Ltd. · 2014 · 3 generations on57descendants
- K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd. · 2018 · 4 generations on38descendants
- K102461FractoraInvasix, Ltd. · 2011 · 2 generations on24descendants
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) | K072394 | Portrait Stand-Off | Rhytec Incorporated | 2007 | — |
| +1 | K073572 | Matrix RF Applicator | Syneron Medical, Ltd. | 2008 | — |
| +2 | K101510 | Fractional Skin Resurfacing (FSR) Applicator | Endymed Medical, Ltd. | 2011 | — |
| +3 | K130501 | Intensif | Endymed Medical, Ltd. | 2014 | — |
| +4 | K180189 | InMode System with Fractora3D/3D-90 Applicators | Inmode MD, Ltd. | 2018 | — |
| +2 | K102461 | Fractora | Invasix, Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 7 | 0 |
| 2021 | 8 | 0 |
| 2022 | 10 | 0 |
| 2023 | 7 | 0 |
| 2024 | 20 | 0 |
| 2025 | 15 | 0 |
| 2026 | 11 | 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 |
|---|---|---|---|
| * | K071786 | Portrait PSRSummary page 1…Classification Name: Electrosurgical cutting and coagulation device Product Code: GEl Legally Market Predicate Devices K071786 Portrait® PSR 3 Device Description The Rhytec, Inc. Portrait® PSR 3 System is an electro-surgical device for use in dermatologic… | 2007 |
What descends from it? (104)
See all 1042 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 12 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 4 of the 31 ancestors have a recall of any class.
- Of its descendants, K073572 (Syneron Medical, Ltd., 2008) has gone furthest, with 102 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. 2007, 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 indicated for treatment of the following dermatological conditions:
* Treatment of wrinkles and rhytides
* Superficial skin lesions
* Actinic Keratosis
* Viral Papillomata
* Seborrhoeic Keratosis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072394 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072394: Portrait Stand-Off.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072394
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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