FDA.reportPublic FDA data

AvalancheLase

Primary DI
03830054230361
Brand
AvalancheLase
Company
FOTONA d.o.o.
Model
M071-2F/LXP
Device description
The AvalancheLase Family is based on Nd:YAG (1064 nm) and Alexandrite (755 nm) laser technology. The laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The unit combines two flashlamp pumped laser sources in one housing, with optical cavities containing the Nd:YAG and Alexandrite crystals. A green diode aiming beam (520 nm) is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an optical fiber delivery system to an optical manual handpiece or scanner. The AvalancheLase Family is designed to operate in single wavelength (Nd:YAG or Alexandrite) configurations (models) and dual wavelength (Nd:YAG and Alexandrite) configurations (models).
Published
2023-03-07
Public version status
Update
Distribution status
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
K223540000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223540000AvalancheLase FamilyFotona D.O.O.2023-01-19GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03830054230361PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03830054230361038300542303613830054230361

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological 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, 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius29 Degrees Celsius
Storage Environment Atmospheric Pressure700 KiloPascal1600 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius50 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
03830054230866XPulse1064 nm2022-12-21
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

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