Home / 510(k) Clearances / K250216

510(k) K250216

OsteoProbe (OP-100) by Active Life Scientific, Inc. — Product Code QGQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 11, 2025
Date Received: January 24, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Bone Indentation Device
Device Class: Class II
Regulation Number: 888.1600
Review Panel: OR
Submission Type

A bone indentation device is a device that measures resistance to indentation in bone.