FDA.reportPublic FDA data

InnoVoyce VYLO Laser

Primary DI
00860004755982
Brand
InnoVoyce VYLO Laser
Company
Innovoyce LLC
Model
A
Catalog number
ASY-300134
Device description
InnoVoyce VYLO Laser
Published
2025-02-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K240159000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240159000InnoVoyce VYLOInnovoyce2024-05-29GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860004755982PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860004755982008600047559828600047559820860004755982

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical diode laser systemAn electrically-powered device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to cut, excise, vaporize, and coagulate tissues for general surgery and/or multiple specialized surgical applications (non-dedicated) such as lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression (PLDD), benign prostatic hyperplasia (BPH) therapy, and ear/nose/throat (ENT) interventions. It includes a diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
617 865 9401info@innovoyce.com

Regulatory Flags#

DUNS number
118104468
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860004755920InnoVoyce Laser FiberAASY-300063-3002023-12-01
00860004755937InnoVoyce Laser FiberAASY-300063-4002023-12-01
00860004755944InnoVoyce Laser FiberAASY-300063-6002023-12-01
00860004755913InnoVoyce LLCAKLF-001-6002024-07-26
00860004755906InnoVoyce LLCAKLF-001-4002024-07-26
00860011812104InnoVoyce VYLO Eye Safety Filter ZeissAASY-3001442025-02-07
00860011812111InnoVoyce VYLO FootswitchAPRT-3010092025-02-07
00860011812180InnoVoyce VYLO CartALC-004552025-02-07
00860004755999InnoVoyce VYLO Eye Safety Filter LeicaAASY-3001432025-02-07
00860011812128InnoVoyce Laser FiberBI0128-ASY-300063-3002024-07-26
00860011812135InnoVoyce Laser FiberBI0128-ASY-300063-4002024-07-26
00860011812142InnoVoyce Laser FiberBI0128-ASY-300063-6002024-07-26
10860004755903InnoVoyce LLCAKLF-001-6002024-07-26
00860011812159InnoVoyce Laser FiberBI0128-ASY-300063-3002024-07-26
00860011812166InnoVoyce Laser FiberBI0128-ASY-300063-4002024-07-26
00860011812173InnoVoyce Laser FiberBI0128-ASY-300063-6002024-07-26
00860004755951InnoVoyce Laser FiberAASY-300063-3002023-12-01
00860004755968InnoVoyce Laser FiberAASY-300063-4002023-12-01
00860004755975InnoVoyce Laser FiberAASY-300063-6002023-12-01

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