# K082622: Alma Lasers Accent B-Shape Massager Handpiece/Module

- Pathway: 510(k) (Traditional)
- Applicant: Alma Lasers, Ltd.
- Decided: Jan 12, 2009 after 125 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: 15 generations back to K943450 (1995). 102 ancestors in all.
45 later devices descend from it; 5 cite it directly.
0 of 148 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080300: Cutera Multimodal Cellulite Product (Cmmcd), Cutera, Inc. (2008) Summary page 1.
- K053611: Smoothshapes, Bicellulase, Inc. (2006) Summary page 1.
- K050397: Velasmooth, Shaper, Syneron Medical, Ltd. (2005) Summary page 1.
- K072699: Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XL, Alma Lasers, Ltd. (2007) Summary page 1.
- K070004: Accent, Alma Lasers, Ltd. (2007) Summary page 1.

## Most influential descendants
- K090580: Thermage Thermacool NXT System and Accessories (2009), 19 descendants of its own
- K120510: Transcend (2013), 18 descendants of its own
- K132431: Thermage CPT System (2013), 17 descendants of its own
- K163415: SlimShape System (2017), 14 descendants of its own
- K170758: Thermage FLX System and Accessories (2017), 13 descendants of its own

## Indications for use
The massage component of the Alma Lasers Accent UniForm Massager Handpiece/Module is intended for use with the Alma Lasers Family of Accent RF Systems to provide: Temporary reduction in the appearance of celuluite. Simultaneous application of RF energy and mechanical manipulation of the skin by the Alma Lasers Accent UniForm Massager Handpiece/Module is intended for use with the Alma Lasers Family of Accent RF Systems to provide: Temporary reduction in the appearance of cellulite.

Source page: https://510kreport.com/device/K082622
Methodology: https://510kreport.com/methodology