# K121150: Alma Lasers Family of Pixel RF Tips

- Pathway: 510(k) (Traditional)
- Applicant: Alma Lasers, Inc.
- Decided: Sep 21, 2012 after 158 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: 18 generations back to K943450 (1995). 273 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 277 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K101147: Modified Alma Lasers Family of Accent Radiofrequency (RF) System, Alma Lasers, Inc. (2011)
- K073572: Matrix RF Applicator, Syneron Medical, Ltd. (2008) Summary page 1.
- K090025: Matrix RF Applicator, Syneron Medical, Ltd. (2010) Summary page 1.
- K083461: Imagine TC Skin Therapy System, Endymion Medical, Ltd. (2009) Summary page 1.
- K101510: Fractional Skin Resurfacing (FSR) Applicator, Endymed Medical, Ltd. (2011) Summary page 1.
- K120513: Glow by Endymed, Endymed Medical, Ltd. (2012). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- 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 Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] is intended for use in dermatologic add general surgical procedures. The Unipolar and Bipolar handpieces, when used as a combined treatment, are indicated for the non-invasive treatment of wrinkles and rhytids. The Pixel RE Tips (stationary and rolling), when used with the unipolar handpiece, are indicated for dermatological procedures requiring ablation and resurfacing of the skin.

Source page: https://510kreport.com/device/K121150
Methodology: https://510kreport.com/methodology