FDA.reportPublic FDA data

InnoVoyce Laser Fiber

Primary DI
00860011812142
Brand
InnoVoyce Laser Fiber
Company
Innovoyce LLC
Model
B
Catalog number
I0128-ASY-300063-600
Device description
InnoVoyce Laser Fiber .600 1 Pack RFID
Published
2024-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00860011812173PackageGS15In Commercial Distribution
00860011812142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011812173008600118121738600118121730860011812173
00860011812142008600118121428600118121420860011812142

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical laser system beam guide, single-useA surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials; a fibreoptic cable may be included with the device. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
118104468
Device count
1
Serial number
true
Expiration 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
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
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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Primary DI, Brand, Company table
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00816995027867Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027874Fraxel FTXSOLTA MEDICALGEX2026-07-20
00816995027904Fraxel FTXSOLTA MEDICALGEX2026-07-20
06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
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08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
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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