FDA UDI
In Commercial Distribution
🇺🇸 United States
LUMIX ULTRA/PLUS
DI: 08057949171577
·
Model: LUMIX ULTRA 1
·
FISIOLINE SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- LUMIX ULTRA/PLUS
- Primary DI
- 08057949171577
- Version / Model
- LUMIX ULTRA 1
- Catalog Number
- LULTRA21HP
- Company Name
- FISIOLINE SRL
- Labeler DUNS
- 338384498
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-14
- Public Version
- 1
- Public Version Date
- 2023-06-22
- Public Version Status
- New
- Public Device Record Key
- 0394b429-4c0a-4ebd-a0d1-057bff483080
Device Description
LASER THERAPY LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910nm+1064nm)
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
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | Physical Medicine | 890.5500 | 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 | 08057949171577 | GS1 |
Customer Contacts
- Phone
- +390172470432
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161198 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 20 | Millimeter | |
| Lumen/Inner Diameter | 650 | Nanometer | |
| Lumen/Inner Diameter | 910 | Nanometer | |
| Lumen/Inner Diameter | 1064 | Nanometer |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 45 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 40 – 60 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 40 – 60 Percent (%) Relative Humidity