Identity
- Trade Name
- Waterlase Laser System Turbo Handpiece FDA UDI
- Generic Name
- Dental solid-state laser system FDA UDI
- Device Name
- A reusable handpiece intended for use with Waterlase laser systems. FDA UDI
- Model / Reference
- 6201126 Refurbished FDA UDI
- Description
- A reusable handpiece intended for use with Waterlase laser systems. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00647529002469 FDA UDI
- 510(k) Number
- K090181 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dental solid-state laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 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
Moist Heat or Steam Sterilization FDA UDI
Waterlase Laser System Turbo Handpiece by Biolase, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K090181 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
- Biolase, Inc.
Sources (1)
- FDA UDI a1208805-8b8d-40ed-8939-2588f1abf6ac 36 fields · synced Jun 6, 2026