# K213344: BTL-899A

- Pathway: 510(k) (Traditional)
- Applicant: BTL Industries, Inc.
- Decided: Jan 5, 2022 after 90 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: 21 generations back to K943450 (1995). 108 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 111 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211107: BTL-899 FP, BTL Industries, Inc. (2021) Summary page 4.

## Most influential descendants
- K230467: BTL-899F (2023), 1 descendant of its own
- K233849: BTL-499 (2024), 0 descendants of its own

## Indications for use
BTL-899A is indicated to be used for: Non-invasive lipolysis (breakdown of fat) of the abdomen. Reduction in circumference of the abdomen. Non-invasive lipolysis (breakdown of fat) of the thighs. Reduction in circumference of the thighs. BTL-899A is intended for use with skin type I - VI. Non-invasive lipolysis (breakdown of fat) of the upper arms limited to skin types II and III and BMI 30 and under.

Source page: https://510kreport.com/device/K213344
Methodology: https://510kreport.com/methodology