Aura Glide (FC40)

Q: When was Aura Glide (FC40) cleared by the FDA?

Aura Glide (FC40) (K252187) received a 510(k) decision of Substantially Equivalent on December 23, 2025, 162 days after the submission was received.

Q: What is the product code of K252187?

The FDA product code is NFO – Stimulator, Transcutaneous Electrical, Aesthetic Purposes, a Class II (moderate risk) device regulated under 21 CFR 882.5890.

FDA 510(k) K252187 · Aura Medical, LLC

Substantially Equivalent

510(k) numberK252187

Submission

Device name: Aura Glide (FC40)
Applicant: Aura Medical, LLC
Brooklyn, NY, US
Received: July 14, 2025
Decision date: December 23, 2025
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: NFO – Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.5890
Specialty: Neurology

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K252621	DeepSkin (DEP100)NFO · Traditional	El Global Trade, Ltd.	05/08/2026SE
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

Questions and answers

When was Aura Glide (FC40) cleared by the FDA?

Aura Glide (FC40) (K252187) received a 510(k) decision of Substantially Equivalent on December 23, 2025, 162 days after the submission was received.

What is the product code of K252187?

The FDA product code is NFO – Stimulator, Transcutaneous Electrical, Aesthetic Purposes, a Class II (moderate risk) device regulated under 21 CFR 882.5890.