# K192224: BTL-899

- Pathway: 510(k) (Traditional)
- Applicant: Btl
- Decided: Dec 5, 2019 after 111 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). 105 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163415: SlimShape System, Syneron Medical, Ltd. (2017) Summary page 4.

## Most influential descendants
- K202199: BTL-899ST (2021), 6 descendants of its own
- K211107: BTL-899 FP (2021), 3 descendants of its own
- K213344: BTL-899A (2022), 2 descendants of its own
- K231495: The Evolve System with the Transform Applicator (2023), 1 descendant of its own
- K230467: BTL-899F (2023), 1 descendant of its own

## Indications for use
BTL-899 is indicated to be used for: • Non-invasive lipolysis (breakdown of fat) of the abdomen. • Reduction in circumference of the abdomen • The BTL-899 is intended for use with Skin Type I to Skin Type III.

Source page: https://510kreport.com/device/K192224
Methodology: https://510kreport.com/methodology