510(k) DEN250028

Clearance Details

Decision

DENG (De Novo Granted)

Decision Date

May 21, 2026

Date Received

June 27, 2025

Clearance Type

Direct

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Software-Aided Adjunctive Diagnostic Device For Use By Healthcare Providers In Skin Wound Assessment.

Device Class

Class II

Regulation Number

878.1840

Review Panel

SU

Submission Type

A software-aided adjunctive diagnostic device for use by healthcare providers in skin wound assessment uses a software algorithm to analyze optical or other physical properties of a skin wound without direct wound contact and returns characterizing information that may include classification, severity, or healing potential of the skin wound. The device is intended for prescription use by healthcare providers to provide adjunctive information to be used in conjunction with clinical assessment. It is not for use as a standalone diagnostic device.