FDA.reportPublic FDA data

OmniGuide RFID Surgical Fibers

Primary DI
04250341910599
Brand
OmniGuide RFID Surgical Fibers
Company
LISA Laser Products GmbH
Model
101 503 xxx
Catalog number
101 503 648
Device description
LISA Laser Surgical Fibers are individually packed sterile devices indicated to provide high quality surgical laser fiber optic delivery systems for laser surgery. The Fibers are intended for use in laser surgical procedures including open, laparoscopic, or endoscopic ablation, coagulation, incision, and excision or vaporizing in any soft/hard-tissue application for which compatible lasers are applicable. The key components of this system are the SMA-905, SMA-906 and Manufacturer’s specific connectors and the Fiber Optic
Published
2026-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250341910599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250341910599042503419105994250341910599

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical laser system beam guide, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315026396
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250341904413Sphinx103 001 010103 001 0102026-01-23
04250341908596RevoLix and RevoLix Jr.105 105 3312026-01-23
04250341908695RevoLix DUO105 301 111105 301 1112026-01-23
04250341910285Sphinx Jr.101 203 311101 203 3112026-01-23
04250341910308Sphinx Jr. 103 201 1112026-01-15
04250341911695RevoLix HTL105 401 0102024-04-04
04250341911572FlexGuard101 503 6312018-09-21
14250341911579FlexGuard101 503 6312018-09-21

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Primary DI, Brand, Company table
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