# K060948: Portrait PSR3

- Pathway: 510(k) (Traditional)
- Applicant: Rhytec Incorporated
- Decided: Sep 5, 2006 after 152 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K943450 (1995). 29 ancestors in all.
110 later devices descend from it; 1 cites it directly.
0 of 140 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041999: Gyrus Plasma Skin Resurfacing System, Gyrus Medical, Inc. (2005) Summary page 1.
- K053365: Modification to Thermage Thermacool System, Thermage, Inc. (2005) Summary page 1.
- K052778: Thermage Thermacool Skin Marketing, Thermage, Inc. (2005) Summary page 1.
- K021402: Thermage Thermacool TC System, Thermage, Inc. (2002) Summary page 1.
- K013639: Thermage Thermacool TC System, Thermage, Inc. (2002) Summary page 1.

## Most influential descendants
- K071786: Portrait PSR (2007), 109 descendants of its own
- K072394: Portrait Stand-Off (2007), 104 descendants of its own
- K073572: Matrix RF Applicator (2008), 102 descendants of its own
- K101510: Fractional Skin Resurfacing (FSR) Applicator (2011), 64 descendants of its own
- K130501: Intensif (2014), 57 descendants of its own

## Recalls of this device
- Oct 2, 2006 · Not classified · Z-0397-2007: Inadequate Directions for Use: Software Upgrade to set maximum energy level at 2.5 Hz

## Indications for use
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

Source page: https://510kreport.com/device/K060948
Methodology: https://510kreport.com/methodology