FDA UDI
In Commercial Distribution
🇺🇸 United States
DEKA SMARTXIDE²
DI: 08057017760276
·
Model: M103AB1
·
EL.EN. SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- DEKA SMARTXIDE²
- Primary DI
- 08057017760276
- Version / Model
- M103AB1
- Catalog Number
- M103AB1
- Company Name
- EL.EN. SPA
- Labeler DUNS
- 436887608
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-15
- Public Version
- 1
- Public Version Date
- 2019-03-25
- Public Version Status
- New
- Public Device Record Key
- d8f2b7bd-c385-4242-9c2a-e010b1995366
Device Description
The SmartXide2 system consists in a 10,600nm carbon dioxide laser (CO2) laser with 80W of maximum power. It can be equipped with an optional diode laser source of 50W maximum power. The laser radiation is delivered to the treatment area through the handpieces or the scanning units. A wide range of handpieces can be provided with the SmartXide² system, having different spot sizes and high performances in specific application field.
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
- 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 |
|---|---|---|---|---|
| 63069 | General/multiple surgical diode/carbon dioxide laser system | A mains electricity (AC-powered) device assembly designed to produce two distinct high-power laser beams, one diode mediated, and the other carbon dixoide (CO2) mediated, intended for aesthetic and tissue reconstructive applications across multiple clinical specialties (e.g., dermatological, gynaecological, urological applications) using both ablative and non-ablative lasing. It includes a laser generator with controls and a monitor. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08057017760276 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K113504 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 35 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal