DermaSensor

Primary DI
00850017786004
Brand
DermaSensor
Company
Dermasensor, Inc.
Model
10101
Published
2024-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

Code, Name table
CodeName
QZSSoftware-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QZSSoftware-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin CancerGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN230008000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN230008000DermaSensorDermasensor, Inc.2024-01-12QZS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850017786004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017786004008500177860048500177860040850017786004

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological elastic scattering spectroscopy probeAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-373-6767support@dermasensor.com

Regulatory Flags#

DUNS number
009483550
Device count
1
Serial number
true