FDA UDI
In Commercial Distribution
🇺🇸 United States
SP Dynamis
DI: 03830054230101
·
Model: M021-4AF/3
·
FOTONA d.o.o.
Product Codes
2
GMDN Terms
3
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SP Dynamis
- Primary DI
- 03830054230101
- Version / Model
- M021-4AF/3
- Company Name
- FOTONA d.o.o.
- Labeler DUNS
- 644720625
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 5
- Public Version Date
- 2022-11-14
- Public Version Status
- Update
- Public Device Record Key
- e2f0a6cd-8cda-428f-8052-d196259e916c
Device Description
The Fotona Dynamis Pro Line of laser systems incorporate lasers that operate in the invisible near- and mid-infrared ranges of the electromagnetic spectrum, as well as an aiming beam laser that operates in the visible range. The Variable Square Pulse (VSP) Technology integrated in Fotona’s laser systems allows control of laser energy and laser pulse length. The Dynamis laser system family is intended to be used in the field of dermatology, aesthetic medicine, gynecology, genitourology and surgery.
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 |
| ONG | Powered Laser Surgical Instrument With Microbeam\Fractional Output | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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 | 03830054230101 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 100 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 500 – 1060 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 29 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 700 – 1060 KiloPascal