# K003183: Thermage Thermacool II System

- Pathway: 510(k) (Traditional)
- Applicant: Thermage, Inc.
- Decided: Dec 8, 2000 after 58 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
No predicates in its family tree.
833 later devices descend from it; 6 cite it directly.
0 of 834 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013034: Modification to: Thermacool Iia (2001), 800 descendants of its own
- 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

Source page: https://510kreport.com/device/K003183
Methodology: https://510kreport.com/methodology