Identity
- Trade Name
- Dental Diode Laser System FDA UDI
- Generic Name
- Dental diode laser system FDA UDI
- Model / Reference
- SOLASE-976 FDA UDI
Identifiers
- Catalog Number
- 07 FDA UDI
- Primary DI / UDI-DI
- 06970750060156 FDA UDI
- 510(k) Number
- K180967 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dental diode 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
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
Moist Heat or Steam Sterilization FDA UDI
Category: Dental diode laser system
Dental Diode Laser System by Lazon Medical Laser Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K180967 also covers:
- Dental Diode Laser System — Lazon Medical Laser Co., Ltd.
- Dental Diode Laser System — Lazon Medical Laser Co., Ltd.
- Dental Diode Laser System — Lazon Medical Laser Co., Ltd.
- Dental Diode Laser System — Lazon Medical Laser Co., Ltd.
- Dental Diode Laser System — Lazon Medical Laser Co., Ltd.
- Dental Diode Laser System — Lazon Medical Laser Co., Ltd.
- Dental Diode Laser System — Lazon Medical Laser Co., Ltd.
- Dental Diode Laser System — Lazon Medical Laser Co., Ltd.
- Dental Diode Laser System — Lazon Medical Laser Co., Ltd.
- Dental Diode Laser System — Lazon Medical Laser Co., Ltd.
- Dental Diode Laser System — Lazon Medical Laser Co., Ltd.
- Dental Diode Laser System — Lazon Medical Laser Co., Ltd.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lazon Medical Laser Co., Ltd.
Sources (1)
- FDA UDI 64968855-179f-4001-9544-087a1262a2ce 34 fields · synced May 30, 2026