Identity
- Trade Name
- ALLORA PRO FDA UDI
- Generic Name
- Multi-modality skin surface treatment system FDA UDI
- Device Name
- The DEKA AGAIN PRO family is a medical laser family equipped with Nd:YAG 1064nm laser. The laser sources deliver the laser output through a lens coupled user repleaceable optical fiber with a wider range of intercheangeable, quick release laser handpieces with electronic spot recognition. FDA UDI
- Model / Reference
- M126AC1 FDA UDI
- Description
- The DEKA AGAIN PRO family is a medical laser family equipped with Nd:YAG 1064nm laser. The laser sources deliver the laser output through a lens coupled user repleaceable optical fiber with a wider range of intercheangeable, quick release laser handpieces with electronic spot recognition. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08057017760818 FDA UDI
- 510(k) Number
- K233090 FDA UDI
- FDA Product Code
- GEX 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
- 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
Yes
FDA UDI
Category: Multi-modality skin surface treatment system
Allora Pro by El.en. Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K233090 also covers:
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
- El.en. Spa
Sources (1)
- FDA UDI fcfcde53-c1ae-4a49-b99d-f7b9b9590c25 35 fields · synced Jun 9, 2026