# K070004: Accent

- Pathway: 510(k) (Traditional)
- Applicant: Alma Lasers, Ltd.
- Decided: Apr 23, 2007 after 110 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: 13 generations back to K943450 (1995). 86 ancestors in all.
181 later devices descend from it; 12 cite it directly.
0 of 268 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 1.
- K031671: Polaris WR, Syneron Medical, Ltd. (2003) Summary page 1.
- K053365: Modification to Thermage Thermacool System, Thermage, Inc. (2005) Summary page 1.
- K040135: Thermage Thermacool System, Thermage, Inc. (2004) Summary page 1.
- K033942: Thermage Thermacool System, Thermage, Inc. (2004) Summary page 1.
- K013034: Modification to: Thermacool Iia, Thermage, Inc. (2001)

## Most influential descendants
- K083461: Imagine TC Skin Therapy System (2009), 101 descendants of its own
- K072699: Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XL (2007), 84 descendants of its own
- K101510: Fractional Skin Resurfacing (FSR) Applicator (2011), 64 descendants of its own
- K130501: Intensif (2014), 57 descendants of its own
- K101967: Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve' (2010), 53 descendants of its own

## Indications for use
The AccentTM device is intended for use in dermatologic and general surgical procedures. The AccentTM device is indicated for use in dermatologic and general surgical procedures for the non-invasive treatment of wrinkles and rhytids using combined treatment with UniPolar and BiPolar..

Source page: https://510kreport.com/device/K070004
Methodology: https://510kreport.com/methodology