FDA.reportPublic FDA data

InnoVoyce Laser Fiber

Primary DI
00860004755968
Brand
InnoVoyce Laser Fiber
Company
Innovoyce LLC
Model
A
Catalog number
ASY-300063-400
Device description
InnoVoyce Laser Fiber .400 1 Pack
Published
2023-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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
K220793000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220793000InnoVoyce Laser FiberInnovoyce, LLC2022-05-25GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860004755968PackageGS15In Commercial Distribution
00860004755937PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860004755968008600047559688600047559680860004755968
00860004755937008600047559378600047559370860004755937

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 617 865 9401Info@InnoVoyce.com

Regulatory Flags#

DUNS number
118104468
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00860004755982InnoVoyce VYLO LaserAASY-3001342025-02-07
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
00860004755975InnoVoyce Laser FiberAASY-300063-6002023-12-01

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Primary DI, Brand, Company table
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08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
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08057017760733DEKA TRUISTEL.EN. SPAGEX2023-04-27
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08057017760276DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760283DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760344DEKA MOTUS AYEL.EN. SPAGEX2019-03-15
08059173390021Youlaser CO2QUANTA SYSTEM SPAGEX2019-01-07
08059173390069Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
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