Identity
- Trade Name
- DEKA PHYSIQ 360 FDA UDI
- Generic Name
- General/multiple surgical diode laser system FDA UDI
- Device Name
- The PHYSIQ 360 is a diode laser device. The device is provided with 4 applicators that deliver the laser energy to the patient (to subcutaneous tissue layers). FDA UDI
- Model / Reference
- M134A1 FDA UDI
- Description
- The PHYSIQ 360 is a diode laser device. The device is provided with 4 applicators that deliver the laser energy to the patient (to subcutaneous tissue layers). FDA UDI
Identifiers
- Catalog Number
- M134A1 FDA UDI
- Primary DI / UDI-DI
- 08057017760689 FDA UDI
- 510(k) Number
- K231971 FDA UDI
- FDA Product Code
- PKT FDA UDI
- GMDN Term
- General/multiple surgical diode laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5400 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: General/multiple surgical diode laser system
Deka Physiq 360 by Deka M.e.l.a. Srl — 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
- Deka M.e.l.a. Srl
Sources (1)
- FDA UDI e68e73ca-87eb-4a56-b49b-991c4030521e 36 fields · synced Jun 9, 2026