Self-Forming Magnet (Flexagon Plus OTOLoc)

• K Number: K253550
• Device Name: Self-Forming Magnet (Flexagon Plus OTOLoc)
• Manufacturer: Gi Windows, Inc.
• Date Cleared: 2026-01-09 ( 56 days)
• Product Code: SAH
• Regulation Number: 878.4816
• Type: Traditional
• Panel: General & Plastic Surgery
• Age Range: N/A
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

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