Beautiful Image Facial Sculpting Device
FDA 510(k) K130065 · Biosonic Technologies, LLC
510(k) numberK130065
Submission
- Device name
- Beautiful Image Facial Sculpting Device
- Applicant
- Biosonic Technologies, LLC
Laguna Niguel, CA, US - Received
- January 10, 2013
- Decision date
- April 30, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code NFO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262861 | PureLift Pro MaxNFO · Special | Xtreem Pulse, LLC | 09/11/2026SE |
| K260387 | SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)NFO · Traditional | Hironic Co., Ltd. | 08/31/2026SE |
| K253932 | FACEGYM Pro Device (HD-109)NFO · Traditional | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 07/23/2026SE |
| K260179 | VITA Multi-Function Head Brush (TB-2343F, TB-2442F)NFO · Traditional | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. | 06/03/2026SE |
| K260895 | Ulike Clear Zero (YC10 BU)NFO · Traditional | Guangxi Ulike Medical Technology Co., Ltd. | 05/28/2026SE |
| K252621 | DeepSkin (DEP100)NFO · Traditional | El Global Trade, Ltd. | 05/08/2026SE |
| K252187 | Aura Glide (FC40)NFO · Traditional | Aura Medical, LLC | 12/23/2025SE |
| K252146 | Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…NFO · Traditional | Shenzhen Siken 3D Technology Development Co., Ltd. | 12/23/2025SE |
| K250618 | Medi Lift Essential Eye MaskNFO · Traditional | Ya-Man, Ltd. | 10/29/2025SE |
| K250227 | JOVS Electric Stimulation Beauty Device (JE2)NFO · Traditional | Shenzhen Qianyu Technology Co., Ltd. | 10/17/2025SE |
Questions and answers
When was Beautiful Image Facial Sculpting Device cleared by the FDA?
Beautiful Image Facial Sculpting Device (K130065) received a 510(k) decision of Substantially Equivalent on April 30, 2014, 475 days after the submission was received.
What is the product code of K130065?
The FDA product code is NFO – Stimulator, Transcutaneous Electrical, Aesthetic Purposes, a Class II (moderate risk) device regulated under 21 CFR 882.5890.