FDA UDI
In Commercial Distribution
🇺🇸 United States
Scar 3 PRO
DI: 08034108512846
·
Model: F540A1
·
DEKA M.E.L.A. SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Scar 3 PRO
- Primary DI
- 08034108512846
- Version / Model
- F540A1
- Company Name
- DEKA M.E.L.A. SRL
- Labeler DUNS
- 629381096
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-04
- Public Version
- 1
- Public Version Date
- 2024-04-12
- Public Version Status
- New
- Public Device Record Key
- 8cff7721-ab89-4dfd-b57c-a7cbd5f8d877
Device Description
The Scar 3 scanning unit is an optional scanner that can be connected to DEKA CO2 lasers. The Scar 3 is composed of the following components: - HiScan Scar 3 head - HiScan Scar 3 cable Laser emission parameters are selected through the GUI of DEKA laser device to whom the scanner is connected. Shape and size of the scanning area may also be selected by using the three keys on the scanning head.
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 |
|---|---|---|---|---|
| 36775 | Skin laser scanner | An electromechanical device intended to enable a laser beam, produced by an appropriate laser, to be scanned uniformly over a broad field of skin, typically for the removal of skin lesions (e.g., birthmarks, pigmentations) and tattoos. A laser beam is typically so intensely focused that only a tiny area can be treated at a time; large areas of skin must be treated using a scanner which sweeps the beam back and forth over the total target area. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08034108512846 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231309 | 000 |