Identity
- Trade Name
- PowerLaser Basic 1600 Platinum FDA UDI
- Generic Name
- Musculoskeletal/physical therapy laser, home-use FDA UDI
- Model / Reference
- 35164 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 57135920351647 FDA UDI
- FDA Product Code
- ILY FDA UDI
- GMDN Term
- Musculoskeletal/physical therapy laser, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5500 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
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
No
FDA UDI
PowerLaser Basic 1600 Platinum by Powermedic ApS — 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
- Powermedic ApS
Sources (1)
- FDA UDI 96ae51e9-c8a3-4650-9561-31c1e8518713 33 fields · synced May 30, 2026