DeepSkin (DEP100)
FDA 510(k) K252621 · El Global Trade, Ltd.
510(k) numberK252621
Submission
- Device name
- DeepSkin (DEP100)
- Applicant
- El Global Trade, Ltd.
Netanya, IL - Received
- August 19, 2025
- Decision date
- May 8, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code NFO
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|---|---|---|---|
| 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 |
| 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 |
| K251034 | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand…NFO · Traditional | Shenzhen Nuon Medical Equipment Co., Ltd. | 10/12/2025SE |
More from Shenzhen Nuon Medical Equipment Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K250341 | Sensilift Pro (ST300XXYYZZZ)PAY · Traditional | 01/06/2026SE |
| K250384 | IPL400OHT · Traditional | 05/23/2025SE |
| K232424 | CurrentBody Skin RFPAY · Traditional | 03/06/2024SE |
| K183260 | Sensilight Pro / Pistol IPLOHT · Traditional | 03/18/2019SE |
| K181095 | RF-ReliefPBX · Traditional | 07/24/2018SE |
| K172181 | micro IPLOHT · Traditional | 10/13/2017SE |
| K170637 | sensiFirmPBX · Traditional | 07/14/2017SE |
| K170499 | sensiLiftPAY · Traditional | 06/15/2017SE |
| K161089 | sensiLight MiniOHT · Traditional | 07/08/2016SE |
| K140381 | Sensilight/ Sensilight PlusOHT · Traditional | 08/08/2014SE |
Questions and answers
When was DeepSkin (DEP100) cleared by the FDA?
DeepSkin (DEP100) (K252621) received a 510(k) decision of Substantially Equivalent on May 8, 2026, 262 days after the submission was received.
What is the product code of K252621?
The FDA product code is NFO – Stimulator, Transcutaneous Electrical, Aesthetic Purposes, a Class II (moderate risk) device regulated under 21 CFR 882.5890.