Identity
- Trade Name
- Apilux FDA UDI
- Generic Name
- Multi-modality skin surface treatment system FDA UDI
- Device Name
- Intense Pulsed Light (IPL) for Treatment of Acne, Vascular Lesions, Pigemented Lesions, Light Hair Removal, Dark HairRemoval FDA UDI
- Model / Reference
- SmartPro II FDA UDI
- Description
- Intense Pulsed Light (IPL) for Treatment of Acne, Vascular Lesions, Pigemented Lesions, Light Hair Removal, Dark HairRemoval FDA UDI
Identifiers
- Catalog Number
- 01-7112 FDA UDI
- Primary DI / UDI-DI
- 00686209171125 FDA UDI
- FDA Product Code
- ONF FDA UDI
- GMDN Term
- Multi-modality skin surface treatment system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Apilux by Dectro International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Dectro International
Sources (1)
- FDA UDI 6e2ac422-8a88-4ade-b65a-fb1e6981bee9 35 fields · synced May 31, 2026