# K160075: Accent XL

- Pathway: 510(k) (Traditional)
- Applicant: Alma Lasers, Inc.
- Decided: Aug 17, 2016 after 216 days
- Product code: IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat)
- Device class: 2
- Regulation: 21 CFR 890.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K943450 (1995). 279 ancestors in all.
No later device cites it as a predicate yet.
0 of 280 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091615: Med Contour, General Project S.R.L. (2010) Summary page 5.
- K121150: Alma Lasers Family of Pixel RF Tips, Alma Lasers, Inc. (2012) Summary page 5.
- K101147: Modified Alma Lasers Family of Accent Radiofrequency (RF) System, Alma Lasers, Inc. (2011) Summary page 3.
- K082622: Alma Lasers Accent B-Shape Massager Handpiece/Module, Alma Lasers, Ltd. (2009) Summary page 5.

## Indications for use
The Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] is intended for use in dermatological 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 hand pieces. The massage component of the Alma Lasers Accent Uniform Hand piece 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. The Unipolar and Bipolar hand pieces, when used as a combined treatment, are indicated for the non-invasive treatment of wrinkles and rhytids. The Pixel RF Tips (stationary and rolling), when used with the unipolar hand piece, are indicated for dermatological procedures requiring ablation and resurfacing of the skin. Ultrasound Module provides ultrasonic diathermy intended for: • Relief of pain • Muscle spasms • Joint contractures • NOT for the treatment of malignancies The hand pieces above are intended to be used with the console cleared in K101147 Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite].

Source page: https://510kreport.com/device/K160075
Methodology: https://510kreport.com/methodology