Identity
- Trade Name
- DEKA SYNCHRO REPLA:Y EXCELLIUM HP FDA UDI
- Generic Name
- Multi-modality skin surface treatment system FDA UDI
- Device Name
- The Synchro Repla:y Excellium HP is a medical laser workstation equipped with an high power Nd:YAG 1064 nm laser. The system can also be equipped with a pulsed light handpieces. FDA UDI
- Model / Reference
- M104L1 FDA UDI
- Description
- The Synchro Repla:y Excellium HP is a medical laser workstation equipped with an high power Nd:YAG 1064 nm laser. The system can also be equipped with a pulsed light handpieces. FDA UDI
Identifiers
- Catalog Number
- M104L1 FDA UDI
- Primary DI / UDI-DI
- 08057017760115 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
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Multi-modality skin surface treatment system
Deka Synchro Repla:y Excellium Hp 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
K131095 also covers:
K150516 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 e5da9042-1920-4806-9044-f0e36ac7a9c5 36 fields · synced Jun 9, 2026