FDA UDI
In Commercial Distribution
🇺🇸 United States
LightScalpel
DI: 00851842007180
·
Model: LS-1005
·
Lightscalpel, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LightScalpel
- Primary DI
- 00851842007180
- Version / Model
- LS-1005
- Catalog Number
- LS9011-02, LS9011-03, LS9011-04, LS9030-01, LS9030-03
- Company Name
- Lightscalpel, LLC
- Labeler DUNS
- 033516010
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2020-08-27
- Public Version Status
- Update
- Public Device Record Key
- 33d84e6e-8e93-4c85-be1a-abe20a76844b
Device Description
LS-1005, 10W CO2 Laser System
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
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 |
|---|---|---|---|---|
| 47878 | Dental carbon dioxide laser system | A mains electricity (AC-powered) Light Amplification by Stimulated Emission of Radiation (LASER) device assembly in which input energy is used to excite carbon dioxide (active medium) to emit a beam of intense, coherent, monochromatic electromagnetic (EM) radiation for application in dental procedures, mainly to excise or vaporize tissue in the oral cavity. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch. It typically emits energy at a wavelength of 10,600 nm (far infrared) to tissues through a handpiece; it may be operated in continuous-wave or pulsed modes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00851842007180 | GS1 |
Customer Contacts
- Phone
- 1-866-697-7548
- [email protected]
Premarket Submissions
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 50 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Non-Condensing
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius