DermaSensor

Basic Information

• Brand Name: DermaSensor
• Primary DI: 00850017786004
• Version / Model: 10101
• Company Name: Dermasensor, Inc.
• Labeler DUNS: 009483550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-09
• Public Version: 1
• Public Version Date: 2024-09-17
• Public Version Status: New
• Public Device Record Key: cd0210cf-db18-4bc9-81ca-49cd1ebdb1c4

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QZS	Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer	General, Plastic Surgery	878.1830	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64023	Dermatological elastic scattering spectroscopy probe	An electrically-powered, hand-held device designed to use elastic scattering spectroscopy (ESS) to non-invasively evaluate a skin lesion clinically suspicious of carcinoma (e.g., melanoma, squamous cell, basal cell) to help guide subsequent clinical steps (e.g., referral, biopsy, excision). Scattered light processed from ESS is used to assess skin cellular and sub-cellular structure. It typically consists of a hand-held probe with controls/display and a tip placed on the skin surface to emit/receive light.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850017786004	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
DEN230008	000