# K090580: Thermage Thermacool NXT System and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Solta Medical, Inc.
- Decided: Jun 26, 2009 after 115 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K943450 (1995). 109 ancestors in all.
19 later devices descend from it; 4 cite it directly.
0 of 129 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033942: Thermage Thermacool System, Thermage, Inc. (2004) Summary page 1.
- K032088: Modification to Thermacool TC System, Thermage, Inc. (2003) Summary page 1.
- K031046: Thermacool TC System, Thermage, Inc. (2003) Summary page 1.
- K043402: Thermage Thermacool System, Thermage, Inc. (2005) Summary page 1.
- K051710: Thermage Thermacool Coupling Fluid, Thermage, Inc. (2005) Summary page 1.
- K052778: Thermage Thermacool Skin Marketing, Thermage, Inc. (2005) Summary page 1.
- K072849: Modification to Thermage Thermacool System, Thermage, Inc. (2008) Summary page 1.
- K050397: Velasmooth, Shaper, Syneron Medical, Ltd. (2005) Summary page 1.
- K070092: Modification to Velasmooth, Shaper, Syneron Medical, Ltd. (2007) Summary page 1.
- K071872: Velashape, Syneron Medical, Ltd. (2007) Summary page 1.
- K082622: Alma Lasers Accent B-Shape Massager Handpiece/Module, Alma Lasers, Ltd. (2009) Summary page 1.
- K030876: Cynosure Triactive Therapeutic Massage System, Cynosure, Inc. (2004) Summary page 1.
- K990445: LPG Therapeutic Massager, Models -Esi, Therapeutic Massager/Vibrator, Lpg USA, Inc. (2000) Summary page 1.

## Most influential descendants
- K132431: Thermage CPT System (2013), 17 descendants of its own
- K170758: Thermage FLX System and Accessories (2017), 13 descendants of its own
- K230663: Density (2023), 2 descendants of its own
- K221989: The Oligio (2022), 2 descendants of its own
- K173759: Thermage CPT System and Accessories (2018), 2 descendants of its own

## Indications for use
The radiofrequency-energy only delivery components of the Thermage ThermaCool NXT System and Accessories are indicated for use in: Dermatologic and general surgical procedures for electrocoagulation and hemostasis; Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids; Non-invasive treatment of wrinkles and rhytids. The simultaneous application of radiofrequency energy and skin vibration by the Thermage ThermaCool NXT System and Accessories is indicated for use in: Dermatologic and general surgical procedures for electrocoagulation and hemostasis; Non-invasive treatment of periorbital wrinkles and rhytids; Non-invasive treatment of wrinkles and rhytids; Temporary improvement in the appearance of cellulite; Relief of minor muscle aches and pains; Relief of muscle spasms; Temporary improvement of local circulation (i.e., blood circulation).

Source page: https://510kreport.com/device/K090580
Methodology: https://510kreport.com/methodology