# K094041: Alpha Orthopaedics AT3 System

- Pathway: 510(k) (Traditional)
- Applicant: Alpha Orthopaedics
- Decided: Apr 7, 2010 after 98 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: 17 generations back to K943450 (1995). 110 ancestors in all.
No later device cites it as a predicate yet.
0 of 111 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090580: Thermage Thermacool NXT System and Accessories, Solta Medical, Inc. (2009) Summary page 1.
- K072849: Modification to Thermage Thermacool System, Thermage, Inc. (2008) Summary page 1.
- K052778: Thermage Thermacool Skin Marketing, Thermage, Inc. (2005) Summary page 1.
- K051710: Thermage Thermacool Coupling Fluid, Thermage, Inc. (2005) Summary page 1.
- K013639: Thermage Thermacool TC System, Thermage, Inc. (2002) Summary page 1.

## Indications for use
The radiofrequency-energy only delivery components of the Alpha Orthopaedlics AT3 System are indicated for use in general surgical procedures for electrocoagulation and hemostasis. The simultaneous application of radiofrequency energy and skin vibration by the Alpha Orthopaedics AT3 System is indicated for use in: * General surgical procedures for electrocoagulation and hemostasis * Relief of minor muscle aches and pain * Relief of muscle spasms * Temporary improvement of local circulation (i.e., blood circulation)

Source page: https://510kreport.com/device/K094041
Methodology: https://510kreport.com/methodology