FDA UDI
In Commercial Distribution
🇺🇸 United States
XPulse
DI: 03830054230866
·
Model: 1064 nm
·
FOTONA d.o.o.
Product Codes
1
GMDN Terms
4
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- XPulse
- Primary DI
- 03830054230866
- Version / Model
- 1064 nm
- Company Name
- FOTONA d.o.o.
- Labeler DUNS
- 644720625
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-21
- Public Version
- 1
- Public Version Date
- 2022-12-29
- Public Version Status
- New
- Public Device Record Key
- 27c5a045-bfae-4f9f-97df-e27ba489d892
Device Description
XPulse® diode lasers are the modern and professional choice for treating soft tissues, haemostasis and for disinfection. With a broad range of clinical presets, handpieces and multiple pulse modalities, XPulse® allows practitioners to perform optimized treatments, with superior battery or plug in operation, for ultimate portability. The device and its accessories are intended to be used in the fields of dentistry, dermatology, surgery and pain management.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- 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 |
|---|---|---|---|---|
| 47880 | Dental 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 to emit a high-power laser beam intended for application in dental procedures; it does not include frequency-doubling technology. It typically includes a light source, delivery/positioning device(s), controls/foot-switch. It is intended to incise, excise, vaporize, ablate, and coagulate oral soft tissue; and cut, shave, contour, and resect oral bone/teeth. Its high-water affinity and high-fluency pulses produce an exceptionally narrow zone of damage around the soft-tissue vaporization crater. | No | Active |
| 36170 | General/multiple surgical 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 to emit a high-power laser beam intended for general surgery and/or multiple specialized surgical applications (non-dedicated), which may include treatment of vascular diseases. It vaporizes/ablates soft tissue with moderate haemostasis, little charring, and a thin zone of necrosis. It includes a light source, delivery/positioning device(s), and controls/foot-switch and emits a midinfrared wavelength. It does not include frequency doubling technology. | No | Active |
| 45223 | Multi-modality skin surface treatment system generator | A mains electricity (AC-powered) mobile (on wheels) device that combines technologies and may include an intense pulsed light (IPL) or IPL with radio-frequency (RF) generator, fluorescent light generator, pulsed ultraviolet B (UVB) light generator, Er:YAG lasers, Er:Glass lasers, long-pulsed Nd:YAG lasers, and Q-switched Nd:YAG lasers, as part of a multi-modality skin surface treatment system intended to be used for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). Dedicated applicators are used to apply the different energies to the skin. | No | Active |
| 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 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03830054230866 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K221712 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 750 – 1080 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 25 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 750 – 1080 KiloPascal