Identity
- Trade Name
- MoleScope Lite FDA UDI
- Generic Name
- Dermatoscope, optical FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 850147000094 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850147000094 FDA UDI
- FDA Product Code
- IBJ FDA UDI
- GMDN Term
- Dermatoscope, optical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3600 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dermatoscope, optical
MoleScope Lite by MetaOptima Technology Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dermatoscope, optical.
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- Diagnostix™ — American Diagnostic Corporation · Class I
- Diagnostix™ — American Diagnostic Corporation · Class I
- DermLite DL1 — DermLite LLC · Class I
- Diagnostix™ — American Diagnostic Corporation · Class I
- Diagnostix™ — American Diagnostic Corporation · Class I
- HEINE diSTANCE — Heine Optotechnik GmbH & Co. KG · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- MetaOptima Technology Inc
Sources (1)
- FDA UDI 871febde-2b2f-43c3-a519-610f18a8810f 34 fields · synced Jun 6, 2026