FDA.reportPublic FDA data

XPulse

Primary DI
03830054230866
Brand
XPulse
Company
FOTONA d.o.o.
Model
1064 nm
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. XPulse and its accessories are intended to be used in dentistry, aesthetics, dermatology, surgery and pain management.
Published
2022-12-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221712000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221712000Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.2022-10-12GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03830054230866PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03830054230866038300542308663830054230866

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical solid-state laser systemA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure75 KiloPascal108 KiloPascal
Handling Environment Humidity0 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature18 Degrees Celsius28 Degrees Celsius
Storage Environment Atmospheric Pressure75 KiloPascal108 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
644720625
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03830054237742StarWalkerM031-3A/2 PICO Pro2025-10-20
03830054238176LightWalker MaxM021-5AF/1 Max2025-07-11
03830054230927SkyPulseM321-A2024-10-04
03830054230934SkyPulseM321-B2024-10-04
03830054230385AvalancheLaseM071-2F/XP2024-09-20
03830054237629TimeWalker ATM021-5AF/12024-09-19
03830054237636TimeWalker ST-EM002-6A/22024-09-19
03830054237681LightWalker AT SM021-5AF/1 S2024-09-19
03830054237698LightWalker ST-E PROM002-6A/2 PRO2024-09-19
03830054237704LightWalker ST-E ADVANCEDM002-6A/2 ADVANCED2024-09-19
03830054230361AvalancheLaseM071-2F/LXP2023-03-07
03830054230378AvalancheLaseM071-2F/LX2023-03-07
03830054230507TimeWalker ATM021-5AF/12021-12-01
03830054230514TimeWalker ST-EM002-6A/22021-12-01
03830054230392SkyPulseM321-A2020-06-23
03830054230408SkyPulseM321-B2020-06-23
03830054230101SP DynamisM021-4AF/32016-09-19
03830054230118XP DynamisM001-12F2016-09-19
03830054230125XS DynamisM002-2A2016-09-19
03830054230163Fotona XP MaxM001-12F2016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851088019BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
08800020109446TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109453TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109460TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109477TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109484TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109491TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109507TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109514TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109521TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109538TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109545TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109552TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109651Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109668Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109675Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109682Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109699Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109705Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109712Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109729Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109989FootswitchJeisys Medical Inc.GEX2026-07-16
08800020109996FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110008FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110275SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110282SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110299SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16