DEVICE: SkyPulse (03830054230927)
Device Identifier (DI) Information
SkyPulse
M321-A
In Commercial Distribution
FOTONA d.o.o.
M321-A
In Commercial Distribution
FOTONA d.o.o.
The Fotona SkyPulse Laser Platform consists of a console, a footswitch and attachable laser modules. The Fotona SkyPulse Laser Platform is a multi-application, multi-technology platform that supports the following modules: i) Flash-lamp pumped solid state laser modules and ii) Diode laser modules. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system microcontroller through an LCD touch-screen. The console allows simultenous attachment of a solid state laser module and a diode module with up to three selectable diode laser wavelengths.
Device Characteristics
| Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 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.
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Active | false |
| 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.
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Active | false |
| 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.
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Active | false |
| 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.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| GEX | Powered Laser Surgical Instrument |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K193656 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
| Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature: between 10 and 25 Degrees Celsius |
| Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
| Storage Environment Temperature: between 0 and 50 Degrees Celsius |
| Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
df6a1a77-9396-428e-a73b-fe8712e7e404
October 14, 2024
1
October 04, 2024
October 14, 2024
1
October 04, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
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Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined