510(k) · Cleared
Recalled · 2006Portrait PSR3
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 5, 2006 as substantially equivalent to K041999 (Gyrus Medical, Inc., 2005) and 4 other predicates after a 152-day review. Its family tree reaches back 12 generations to 1995. 110 later devices descend from it. It has been recalled once.
- Decided
- Sep 5, 2006
- Review
- 152 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 12 generations to K943450 (1995). 29 ancestors in all, the oldest K800617 (1980). 110 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 8 generations between
- 3 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 2 generations backK032088 Modification to Thermacool TC SystemThermage, Inc. · 2003
- 1 generation backK052778 Thermage Thermacool Skin MarketingThermage, Inc. · 2005
- This deviceK060948 Portrait PSR3Rhytec Incorporated · 2006
- Descendant · cites it directly · 109 of its ownK071786 Portrait PSRRhytec Incorporated · 2007
- Descendant · 2 generations on · 104 of its ownK072394 Portrait Stand-OffRhytec Incorporated · 2007
- Descendant · 3 generations on · 102 of its ownK073572 Matrix RF ApplicatorSyneron Medical, Ltd. · 2008
- Descendant · 4 generations on · 64 of its ownK101510 Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd. · 2011
- Descendant · 5 generations on · 57 of its ownK130501 IntensifEndymed Medical, Ltd. · 2014
Show all 12 generations
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 10 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 9 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 8 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 7 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 6 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 5 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 4 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 3 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 2 generations backK032088 Modification to Thermacool TC SystemThermage, Inc. · 2003
- 1 generation backK052778 Thermage Thermacool Skin MarketingThermage, Inc. · 2005
- This deviceK060948 Portrait PSR3Rhytec Incorporated · 2006
Showing 5 of 110 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 110 · See all- K071786Portrait PSRRhytec Incorporated · 2007 · cites it directly109descendants
- K072394Portrait Stand-OffRhytec Incorporated · 2007 · 2 generations on104descendants
- K073572Matrix RF ApplicatorSyneron Medical, Ltd. · 2008 · 3 generations on102descendants
- K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd. · 2011 · 4 generations on64descendants
- K130501IntensifEndymed Medical, Ltd. · 2014 · 5 generations on57descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −11 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −10 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −9 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −8 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −7 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −6 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −5 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −4 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −3 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −2 | K032088 | Modification to Thermacool TC System | Thermage, Inc. | 2003 | — |
| −1 | K052778 | Thermage Thermacool Skin Marketing | Thermage, Inc. | 2005 | — |
| 0 (this device) | K060948 | Portrait PSR3 | Rhytec Incorporated | 2006 | — |
| +1 | K071786 | Portrait PSR | Rhytec Incorporated | 2007 | — |
| +2 | K072394 | Portrait Stand-Off | Rhytec Incorporated | 2007 | — |
| +3 | K073572 | Matrix RF Applicator | Syneron Medical, Ltd. | 2008 | — |
| +4 | K101510 | Fractional Skin Resurfacing (FSR) Applicator | Endymed Medical, Ltd. | 2011 | — |
| +5 | K130501 | Intensif | Endymed Medical, Ltd. | 2014 | — |
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 |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 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 | 11 | 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? (5)
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 |
|---|---|---|---|
| * | K041999 | Gyrus Plasma Skin Resurfacing SystemSummary page 1…Product Code: GEl 3. Predicate Devices The Portrait PSR3 is substantially equivalent to the Gyrus Medical, Inc. Plasma Skin Resurfacing (PSR) System (K041999) and the Thermage ThermaCool System (K053365, K052778, K021402, and K013639). 4. Device Description The Rhytec,… | 2005 |
| * | K053365 | Modification to Thermage Thermacool SystemSummary page 1…The Portrait PSR3 is substantially equivalent to the Gyrus Medical, Inc. Plasma Skin Resurfacing (PSR) System (K041999) and the Thermage ThermaCool System (K053365, K052778, K021402, and K013639). 4. Device Description The Rhytec, Inc. Portrait PSR3 is an electro-surgical device fo… | 2005 |
| * | K052778 | Thermage Thermacool Skin MarketingSummary page 1…ait PSR3 is substantially equivalent to the Gyrus Medical, Inc. Plasma Skin Resurfacing (PSR) System (K041999) and the Thermage ThermaCool System (K053365, K052778, K021402, and K013639). 4. Device Description The Rhytec, Inc. Portrait PSR3 is an electro-surgical device for use in… | 2005 |
| * | K021402 | Thermage Thermacool TC SystemSummary page 1…is substantially equivalent to the Gyrus Medical, Inc. Plasma Skin Resurfacing (PSR) System (K041999) and the Thermage ThermaCool System (K053365, K052778, K021402, and K013639). 4. Device Description The Rhytec, Inc. Portrait PSR3 is an electro-surgical device for use in der… | 2002 |
| * | K013639 | Thermage Thermacool TC SystemSummary page 1…lly equivalent to the Gyrus Medical, Inc. Plasma Skin Resurfacing (PSR) System (K041999) and the Thermage ThermaCool System (K053365, K052778, K021402, and K013639). 4. Device Description The Rhytec, Inc. Portrait PSR3 is an electro-surgical device for use in dermatological a… | 2002 |
What descends from it? (110)
See all 1101 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071786 | Portrait PSR | 2007 | 109 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 2, 2006 | Not classified | Z-0397-2007 | Other | Inadequate Directions for Use: Software Upgrade to set maximum energy level at 2.5 Hz |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 3 of the 29 ancestors have a recall of any class.
- Of its descendants, K071786 (Rhytec Incorporated, 2007) has gone furthest, with 109 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.
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 PSR3 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/K060948 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060948: Portrait PSR3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060948
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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