# K083461: Imagine TC Skin Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Endymion Medical, Ltd.
- Decided: Jul 24, 2009 after 245 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: 14 generations back to K943450 (1995). 87 ancestors in all.
101 later devices descend from it; 12 cite it directly.
0 of 189 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051214: Aluma Skin Renewal System, Lumenis, Inc. (2005) Summary page 2.
- K070004: Accent, Alma Lasers, Ltd. (2007) Summary page 2.
- K053365: Modification to Thermage Thermacool System, Thermage, Inc. (2005) Summary page 2.
- K031671: Polaris WR, Syneron Medical, Ltd. (2003) Summary page 2.

## Most influential descendants
- K101510: Fractional Skin Resurfacing (FSR) Applicator (2011), 64 descendants of its own
- K130501: Intensif (2014), 57 descendants of its own
- K180189: InMode System with Fractora3D/3D-90 Applicators (2018), 38 descendants of its own
- K100586: Venus Freeze System (2010), 31 descendants of its own
- K192545: Potenza (2020), 20 descendants of its own

## Indications for use
The Imagine TC Skin Treatment System is a noninvasive device intended for use in Dermatologic and General Surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides

Source page: https://510kreport.com/device/K083461
Methodology: https://510kreport.com/methodology