# K101147: Modified Alma Lasers Family of Accent Radiofrequency (RF) System

- Pathway: 510(k) (Traditional)
- Applicant: Alma Lasers, Inc.
- Decided: Jan 21, 2011 after 273 days
- Product code: NUV (Massager, Vacuum, Light Induced Heating)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K943450 (1995). 103 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070004: Accent, Alma Lasers, Ltd. (2007) Summary page 1.
- K072699: Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XL, Alma Lasers, Ltd. (2007) Summary page 1.
- K082622: Alma Lasers Accent B-Shape Massager Handpiece/Module, Alma Lasers, Ltd. (2009) Summary page 1.

## Most influential descendants
- K121150: Alma Lasers Family of Pixel RF Tips (2012), 3 descendants of its own
- K201520: The Alma Opus System, Colibri Applicator and Tips (2021), 1 descendant of its own
- K233760: Mjolnir Pro. (Multi–electrode plasma) (2024), 0 descendants of its own
- K160075: Accent XL (2016), 0 descendants of its own

## Indications for use
The Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] is intended for use in dermatologic and general surgical procedures. The Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] is indicated for the non-invasive treatment of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar handpieces. The massage component of the Alma Lasers Accent UniForm Handpiece is intended for use with the Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] to provide: * Temporary reduction in the appearance of cellulite. Simultaneous application of the RF energy and mechanical manipulation of the skin is intended for use with the Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] to provide: * Temporary reduction in the appearance of cellulite.

Source page: https://510kreport.com/device/K101147
Methodology: https://510kreport.com/methodology