Page 55 - Noninvasive Diagnostic Techniques for the Detection of Skin Cancers

Appendix C. FDA Clearance and Clinical Trials Status

Table C-1. Available U.S. FDA clearance status for noninvasive skin cancer diagnostic devices
Device name Company (country) FDA clearance status Intended use
Web site
DERMOSCOPY
EpiScope Welch Allyn (USA) • Approved by the FDA Class I To illuminate body
(MODEL www.welchallyn.com device surfaces and cavities
47300) • 510(K920103)
• FDA decision date: 04/28/1992
Nevoscope TransLite (USA) • Approved by the FDA as Class To view skin lesions
www.tlite.com I device by either surface
• 510(K954943) illumination or
• FDA decision date: 03/27/1996 transillumination
Dermascope American Diagnostic • Approved by the FDA as Class To enlarge images
Corp. (USA) I device in 1999 for medical purposes
www.adctoday.com
MoleMax Derma Medical Systems • Approved by the FDA as Class To enlarge images
www.dermamedicalsyste I device in 1999 for medical purposes
ms.com
MicroDerm Visiomed AG (USA) • Approved by the FDA as Class To acquire and store
www.visiomedag.com II device images of skin
• 510(K032760) surfaces
• FDA decision date: 04/27/2004
CONFOCAL MICROSCOPY
VivaScope® Lucid, Inc. (USA) • Approved by the FDA as Class To acquire, store,
1500 www.lucid-tech.com II device retrieve, display, and
VivaScope® • 510(k) number: K080788 transfer in vivo
2500 • FDA decision date: 09/05/2008 images of tissue
VivaScope®
3000
Optiscan™ Optiscan Pty Ltd • Approved by the FDA as Class This device was
(Australia) II device listed as a confocal
www.optiscan.com • 510(k) number: K093624 microscopy device for
• FDA decision date: 02/19/2010 skin lesion evaluation
in a published
37
review. However,
the intended use
listed in the FDA
summary is for the
imaging of the
internal
microstructure of
tissues during
endoscopic medical
procedures.

C-1