# K211639: BTL-785W

- Pathway: 510(k) (Traditional)
- Applicant: BTL Industries, Inc.
- Decided: Mar 7, 2022 after 284 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: 23 generations back to K943450 (1995). 287 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 295 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193201: BTL-785F, Btl (2020) Summary page 6.
- K092191: Exilis, Model 5000, Btl Industries, Ltd. (2009) Summary page 6.
- K200241: TempSure System, Cynosure, LLC (2020) Summary page 6.

## Most influential descendants
- 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
- 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

## Indications for use
The BTL-785W device has the following indications for use: The BTL-785W 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-785W 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-785W 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 Applicator BTL-785-4 of BTL-785W device 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-785F 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-785-7 hands-free applicator of BTL-785W used with BTL-785-7-1, BTL-785-7-2, BTL-785-7-3, BTL-785-7-4, BTL-785-7-5, BTL-785-7-6 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.

Source page: https://510kreport.com/device/K211639
Methodology: https://510kreport.com/methodology