SHY

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

Product code

SHY

Device name

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

Device class

Class 2

21 CFR

21 CFR 878.1840

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

0 (direct download)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-05-21.