FDA UDI
In Commercial Distribution
🇺🇸 United States
LightMed
DI: 04719882550010
·
Model: SA-108
·
LIGHTMED DENTAL TECHNOLOGY CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LightMed
- Primary DI
- 04719882550010
- Version / Model
- SA-108
- Catalog Number
- Saphhire
- Company Name
- LIGHTMED DENTAL TECHNOLOGY CORPORATION
- Labeler DUNS
- 656103679
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-20
- Public Version
- 2
- Public Version Date
- 2022-07-14
- Public Version Status
- Update
- Public Device Record Key
- bfb2ba0a-0041-40fa-b26c-38da88e5fe6b
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47880 | Dental solid-state laser system | A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for application in dental procedures; it does not include frequency-doubling technology. It typically includes a light source, delivery/positioning device(s), controls/foot-switch. It is intended to incise, excise, vaporize, ablate, and coagulate oral soft tissue; and cut, shave, contour, and resect oral bone/teeth. Its high-water affinity and high-fluency pulses produce an exceptionally narrow zone of damage around the soft-tissue vaporization crater. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04719882550010 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170073 | 000 |