Identity
- Trade Name
- PerioLase FDA UDI
- Generic Name
- General/multiple surgical solid-state laser system FDA UDI
- Device Name
- The PerioLase is a FR Nd:YAG laser producing laser emission at 1064nm with variable pulse durations. The laser consists of two interconnected sections: the cabinet which houses the laser head, the power supply, the cooling system and the microprocessor with control panel; and the fiber optic delivery system which includes the Fiberflex fiber and Trueflex handpiece. FDA UDI
- Model / Reference
- MVP-7 FDA UDI
- Description
- The PerioLase is a FR Nd:YAG laser producing laser emission at 1064nm with variable pulse durations. The laser consists of two interconnected sections: the cabinet which houses the laser head, the power supply, the cooling system and the microprocessor with control panel; and the fiber optic delivery system which includes the Fiberflex fiber and Trueflex handpiece. FDA UDI
Identifiers
- Catalog Number
- VIII FDA UDI
- Primary DI / UDI-DI
- D808VIII1 FDA UDI
- 510(k) Number
- K030290 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical solid-state laser 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
No
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 solid-state laser system
PerioLase by Millennium Dental Technologies, Inc. — 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
- Millennium Dental Technologies, Inc.
Sources (1)
- FDA UDI 16778ee5-5f40-49d1-b45e-87cf08f0726d 36 fields · synced Jun 9, 2026