FDA UDI
In Commercial Distribution
🇺🇸 United States
MT ONE DIAMOND
DI: 08057622080042
·
Model: MT ONE DIAMOND
·
M & T SRL
Product Codes
4
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MT ONE DIAMOND
- Primary DI
- 08057622080042
- Version / Model
- MT ONE DIAMOND
- Company Name
- M & T SRL
- Labeler DUNS
- 441794981
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-15
- Public Version
- 2
- Public Version Date
- 2025-07-14
- Public Version Status
- Update
- Public Device Record Key
- 77ff2331-137a-4a91-a0e6-83ed5d83f9a9
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
- MR Unsafe
- 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 |
| ONE | Powered Light Based Non-Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | General, Plastic Surgery | 878.4810 | 2 |
| ONG | Powered Laser Surgical Instrument With Microbeam\Fractional Output | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47883 | Dermatological 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, or a fibre doped with a glass/crystal element (known as fibre laser), to emit a high-power laser beam intended to incise, excise, ablate, and vaporize soft tissues for dermatological applications such as skin resurfacing, acne treatment, and/or lesion/hair/tattoo removal; some types may also be used for coagulation/haemostasis procedures; it is not intended for hair loss therapy. It typically includes a light source, laser beam delivery/positioning device(s), user interface, and controls/foot-switch; it does not include frequency-doubling technology. | No | Active |
| 58786 | Dermatological diode laser system | A mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam designed to perform dermatological procedures such as body hair removal (e.g., armpit, leg/arm, back, chest, bikini line, and face) and/or skin resurfacing (e.g., treatment of benign lesions, wrinkle reduction). It is intended to be used by a trained professional to emit pulsed light of a specific wavelength (e.g., around 808 nm or 1060 nm), delivered by a dedicated handpiece. It typically includes a control unit with dedicated software and user interface, delivery handpiece, and footswitch. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08057622080042 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191942 | 000 |