Submission Details
| 510(k) Number | K252187 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 14, 2025 |
| Decision Date | December 23, 2025 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
Aura Glide (FC40)
Dec 2025
Decision
162d
Days
Class 2
Risk
About This 510(k) Submission
K252187 is an FDA 510(k) clearance for the Aura Glide (FC40), a Stimulator, Transcutaneous Electrical, Aesthetic Purposes (Class II — Special Controls, product code NFO), submitted by Aura Medical, LLC (Brooklyn, US). The FDA issued a Cleared decision on December 23, 2025, 162 days after receiving the submission on July 14, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.
Device Classification
| Product Code | NFO — Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.5890 |
Manufacturer
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