FDA.reportPublic FDA data

MoleScope II

Primary DI
85014700007024
Brand
MoleScope II
Company
MetaOptima Technology Inc
Model
850147000070
Device description
MoleScope is a battery-powered dermatoscope intended to be attached to smartphones and tablets to take images of skin, scalp, hair, nail, and other body surfaces with high magnification and cross-polarized light. It is a reusable, non-invasive device for imaging and documentation only.
Published
2023-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KYTLight, Examination, Medical, Battery Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYTLight, Examination, Medical, Battery PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
85014700007024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
8501470000702485014700007024

GMDN Terms#

Term, Definition table
TermDefinition
Dermatoscope, opticalAn 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).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1778328194info@metaoptima.com

Regulatory Flags#

DUNS number
203070479
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00627843751328MoleScope II6278437513282023-02-17
00627843751342MoleScope II6278437513422023-02-17
00627843751380MoleScope II6278437513802023-02-17
00627843751397MoleScope II6278437513972023-02-17
00627843751403MoleScope II6278437514032023-02-17
00850147000018MoleScope II8501470000182023-02-17
00850147000049MoleScope II8501470000492023-02-17
00850147000063MoleScope II8501470000632023-02-17
00850147000070MoleScope II8501470000702023-02-17
00850147000087MoleScope II8501470000872023-02-17
00850147000094MoleScope Lite8501470000942023-02-17
62784375132862MoleScope II6278437513282023-02-17
62784375134224MoleScope II6278437513422023-02-17
62784375138048MoleScope II6278437513802023-02-17
62784375139724MoleScope II6278437513972023-02-17
62784375140300MoleScope II6278437514032023-02-17
85014700001848MoleScope II8501470000182023-02-17
85014700004986MoleScope II8501470000492023-02-17
85014700006348MoleScope II8501470000632023-02-17
85014700008700MoleScope II8501470000872023-02-17

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Primary DI, Brand, Company table
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04053755201617DELTA 30 PROHeine Optotechnik GmbH & Co. KGKYT2024-02-06
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