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510(k) DEN250005

Sana Device by Sana Health — Product Code QYN

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: January 16, 2026
Date Received: March 3, 2025
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Prescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use)
Device Class: Class I
Regulation Number: 890.5775
Review Panel: NE
Submission Type

An AVS is a prescription use device intended for temporary pain relief and is used adjunctively with other pain therapies