# K130065: Beautiful Image Facial Sculpting Device

- Pathway: 510(k) (Traditional)
- Applicant: Biosonic Technologies, LLC
- Decided: Apr 30, 2014 after 475 days
- Product code: NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011935 (2001). 3 ancestors in all.
17 later devices descend from it; 5 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072260: Nuface, Model NU-4003, Carol Cole Company (2007) Summary page 4.

## Most influential descendants
- K162652: Smart Photon Micro-current Device, Model: EP-300 (2017), 10 descendants of its own
- K241102: Luna 4 plus (2024), 5 descendants of its own
- K213039: Micro-current facial cold and hot service (model: TPML-100) (2022), 4 descendants of its own
- K243423: LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB) (2025), 3 descendants of its own
- K243430: Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) (2024), 3 descendants of its own

## Indications for use
The Beautiful Image Model 900 Facial Toning Device uses microcurrent electrical energy to stimulate facial tissues for aesthetic purposes.

Source page: https://510kreport.com/device/K130065
Methodology: https://510kreport.com/methodology