# K180359: BTL-FR2000

- Pathway: 510(k) (Traditional)
- Applicant: BTL Industries, Inc.
- Decided: Dec 13, 2018 after 307 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: 17 generations back to K943450 (1995). 257 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 267 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121481: Infini Radiofrequency System, Lutronic Corporation (2013) Summary page 6.
- K090025: Matrix RF Applicator, Syneron Medical, Ltd. (2010) Summary page 6.

## Most influential descendants
- K193201: BTL-785F (2020), 8 descendants of its own
- K211639: BTL-785W (2022), 7 descendants of its own
- K222556: BTL-785X (2023), 5 descendants of its own
- K233604: BTL-785S (2024), 3 descendants of its own
- K242532: BTL-785BNF-E (2024), 1 descendant of its own

## Indications for use
The Applicator 786-1 of BTL-FR2000 device is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The Applicator 786-2 of BTL-FR2000 device is intended for dermatological procedures requiring fractional treatment of the skin.

Source page: https://510kreport.com/device/K180359
Methodology: https://510kreport.com/methodology