Identity
- Trade Name
- PRISMA FDA UDI
- Generic Name
- Multi-modality skin surface treatment system FDA UDI
- Device Name
- The DEKA PRISMA is a device provided with two pulsed light handpieces and a RF handpiece. The overall weight is approximately 62 kg and the sizes 47 x 56 x 106 cm (LxWxH) without external parts and reclined display and 47 x 56 x 202 cm (LxWxH) with handpiece holders at maximum extension Electrical requirements: 115V~, 50/60Hz, 2300VA. The operator interacts directly with the external portions of the system displayed in the following. FDA UDI
- Model / Reference
- M135A1 FDA UDI
- Description
- The DEKA PRISMA is a device provided with two pulsed light handpieces and a RF handpiece. The overall weight is approximately 62 kg and the sizes 47 x 56 x 106 cm (LxWxH) without external parts and reclined display and 47 x 56 x 202 cm (LxWxH) with handpiece holders at maximum extension Electrical requirements: 115V~, 50/60Hz, 2300VA. The operator interacts directly with the external portions of the system displayed in the following. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08034108512464 FDA UDI
- FDA Product Code
- ONF FDA UDIGEI FDA UDI
- GMDN Term
- Multi-modality skin surface treatment system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI878.4400 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
Prisma by Deka M.e.l.a. Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multi-modality skin surface treatment system.
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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
- Deka M.e.l.a. Srl
Sources (1)
- FDA UDI 3412f2d4-2a4b-4fcd-91af-54f5245a362e 34 fields · synced Jun 9, 2026