# K201520: The Alma Opus System, Colibri Applicator and Tips

- Pathway: 510(k) (Traditional)
- Applicant: Alma Lasers, Inc.
- Decided: Oct 27, 2021 after 506 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: 19 generations back to K943450 (1995). 274 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 276 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121150: Alma Lasers Family of Pixel RF Tips, Alma Lasers, Inc. (2012) Summary page 4.

## Most influential descendants
- K233760: Mjolnir Pro. (Multi–electrode plasma) (2024), 0 descendants of its own

## Indications for use
The Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite, and Opus] is intended for use in dermatologic and general surgical procedures. The Opus Plasma Applicator and Tips - The Opus Plasma Tips (Focus and Glide), when used with the unipolar applicator, are indicated for dermatological procedures requiring ablation and resurfacing of the skin. The Opus Colibri Applicator and Tips The Opus Colibri Tips, when used with the unipolar Opus Colibri applicator, are indicated for dermatological procedures requiring resurfacing of the skin.

Source page: https://510kreport.com/device/K201520
Methodology: https://510kreport.com/methodology