Identity
- Trade Name
- iProElite FDA UDI
- Generic Name
- Dermatological diode laser system FDA UDI
- Device Name
- iProElite - Diode Laser System - FDA 510(k) K212478 FDA UDI
- Model / Reference
- iProElite FDA UDI
- Description
- iProElite - Diode Laser System - FDA 510(k) K212478 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860007876837 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological diode laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dermatological diode laser system
iProElite by MDElite Laser and Aesthetic, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- MDElite Laser and Aesthetic, LLC
Sources (1)
- FDA UDI e8cbd8e5-f00a-4fc0-bb3b-6fd1bc2970b6 33 fields · synced May 30, 2026