MoleMate

Basic Information

• Brand Name: MoleMate
• Primary DI: 00628451918035
• Version / Model: V
• Company Name: MedX Health Corp
• Labeler DUNS: 202128257
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 4
• Public Version Date: 2018-10-17
• Public Version Status: Update
• Public Device Record Key: d0ddde97-2bdc-4342-bed4-6ed9d297ba9f

Device Description

Molemate is a software management system for the SIAScope that displays five unique views: dermatoscopic, blood supply, pigment, dermal pigment and collagen.The SIAscope is a quick, non-invasive device for imaging skin conditions. It uses a technique known as ‘Spectrophotometric Intracutaneous Analysis’ (SIAscopy) to identify and display graphically the separate components of the skin. SIAscopy uses a digital camera and light (both visible and near-infrared) to investigate the skin’s interior structure.The SIAscope operates by illuminating the skin with LEDs and measuring the intensity of remitted light. The intensity of the illumination is similar to the emission from a typical hand held torch or remote control unit.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• 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
PSN	Light Based Imaging	General, Plastic Surgery	878.4580	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32696	Skin transilluminator, battery-powered	A hand-held, battery-powered device with a built-in light source, usually together with a lens, intended to be used to illuminate the skin and soft tissues, rendering them translucent for examination. It is typically used to examine subcutaneous and scrotal tissue/contents for lesions, and veins (e.g., on the scalp of an infant) for anatomical abnormalities. This device may also be known as a diaphanoscope, a phaneroscope or a light scanner.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	00628451918004	GS1
Primary	00628451918035	GS1
Package	10628451918032	GS1		1	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K062736	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 30 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 30 – 80 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius