# K222556: BTL-785X

- Pathway: 510(k) (Traditional)
- Applicant: BTL Industries, Inc.
- Decided: May 31, 2023 after 281 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: 24 generations back to K943450 (1995). 288 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 294 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211639: BTL-785W, BTL Industries, Inc. (2022) Summary page 6.
- K092191: Exilis, Model 5000, Btl Industries, Ltd. (2009) Summary page 6.

## Most influential descendants
- K233604: BTL-785S (2024), 3 descendants of its own
- K242532: BTL-785BNF-E (2024), 1 descendant of its own
- K260945: Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension Kit 1 (UL-800-Shape-Ext-Kit-1);Ultimate Shape Extension Kit 2 (UL-800-Shape-Ext-Kit-2) (2026), 0 descendants of its own
- K253750: BTL-785NEH (2026), 0 descendants of its own
- K233849: BTL-499 (2024), 0 descendants of its own

## Indications for use
The BTL-785X device has the following indications for use: The BTL-785X with BTL-785-1 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785-1-4 massage device is intended to provide a temporary reduction in the appearance of cellulite. The BTL-785X with BTL-785-2 applicator is indicated to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785X with BTL-785-3 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785X with BTL-785-4 applicator used with tips BTL-785-4-1, BTL-785-4-2, BTL-785-4-5 and BTL-785-4-6 is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The Applicator BTL-785-4 of BTL-785X device used with tips BTL-785-4-3, BTL-785-4-4, BTL-785-4-7 and BTL-785-4-8 is intended for dermatological procedures requiring fractional treatment of the skin. At higher energy levels greater than 62 mJ/pin, use of the BTL-785-4 applicator is limited to Skin Types I-IV. The BTL-785X with BTL-785-7 hands-free applicator used with forehead BTL-785-7-1 and cheek BTL-785-7-2 single-use electrodes is intended to provide: - heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. - non-invasive temporary reduction of facial wrinkles

Source page: https://510kreport.com/device/K222556
Methodology: https://510kreport.com/methodology