# K013034: Modification to: Thermacool Iia

- Pathway: 510(k) (Special)
- Applicant: Thermage, Inc.
- Decided: Oct 4, 2001 after 24 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: 7 generations back to K943450 (1995). 20 ancestors in all.
800 later devices descend from it; 5 cite it directly.
0 of 821 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000944: Thermage Thermacool System, Thermage, Inc. (2000) Summary page 1.
- K003183: Thermage Thermacool II System, Thermage, Inc. (2000) Summary page 1.

## Most influential descendants
- K013639: Thermage Thermacool TC System (2002), 799 descendants of its own
- K021402: Thermage Thermacool TC System (2002), 789 descendants of its own
- K030142: Thermacool TC System (2003), 773 descendants of its own
- K031671: Polaris WR (2003), 678 descendants of its own
- K033942: Thermage Thermacool System (2004), 527 descendants of its own

## Indications for use
The ThermaCool IIA System is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Source page: https://510kreport.com/device/K013034
Methodology: https://510kreport.com/methodology