MoleScope Lite

Basic Information

• Brand Name: MoleScope Lite
• Primary DI: 00850147000094
• Version / Model: 850147000094
• Company Name: MetaOptima Technology Inc
• Labeler DUNS: 203070479
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-17
• Public Version: 3
• Public Version Date: 2024-11-01
• Public Version Status: Update
• Public Device Record Key: 871febde-2b2f-43c3-a519-610f18a8810f

Device Description

MoleScope™Lite is a handheld magnifier intended for examining intact skin, nail and hair by laypersons and healthcare professionals. Optionally, MoleScope™ Lite can be attached to a smartphone or tablet to capture digital images within the specifications of the mobile device.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
IBJ	Light, Microscope	Pathology	864.3600	1

GMDN Terms

Code	Name	Definition	Implantable	Status
18021	Dermatoscope, optical	An electrically-powered, hand-held instrument intended to be used for the direct microscopic examination of the external skin layers. The device has a built-in light source and magnification system that provides the user with the visualization of the structures of the epidermis and epidermal-dermal junction during dermatoscopy (also known as dermascopy). Oil may be applied to the skin to enhance skin transparency. This device is commonly used for the examination of skin structures and to assess abnormal colour and pattern changes of pigmented skin lesions (e.g., spongy birth marks, malignant melanoma).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850147000094	GS1

Customer Contacts

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