Identity
- Trade Name
- LightMed FDA UDI
- Generic Name
- Dental solid-state laser system FDA UDI
- Device Name
- LightMed Dental Laser System is intended to assist during dental procedures performed in oral and maxillofacial surgery and dentistry. The Erbium YAG laser is indicated for a variety of hard tissue, soft tissue and bone applications. It is also indicated for incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistry. FDA UDI
- Model / Reference
- SA-108 FDA UDI
- Description
- LightMed Dental Laser System is intended to assist during dental procedures performed in oral and maxillofacial surgery and dentistry. The Erbium YAG laser is indicated for a variety of hard tissue, soft tissue and bone applications. It is also indicated for incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistry. FDA UDI
Identifiers
- Catalog Number
- Saphhire FDA UDI
- Primary DI / UDI-DI
- 04719882550010 FDA UDI
- 510(k) Number
- K170073 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
- 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental solid-state laser system
LightMed by Lightmed Dentaltechnology Corp. — 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
- Lightmed Dentaltechnology Corp.
Sources (1)
- FDA UDI bfb2ba0a-0041-40fa-b26c-38da88e5fe6b 35 fields · synced May 30, 2026