FDA.reportPublic FDA data

300 micron laser fiber (KTP)

Primary DI
00810077631362
Brand
300 micron laser fiber (KTP)
Company
OPTICAL INTEGRITY INC
Model
11911
Device description
300-micron laser fiber, single use disposable (KTP)
Published
2024-09-06
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810077631362PackageGS15In Commercial Distribution
00810077631379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810077631362008100776313628100776313620810077631362
00810077631379008100776313798100776313790810077631379

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter300Micrometer

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius37 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
850-233-5512sales@opticalintegrity.com

Regulatory Flags#

DUNS number
024050887
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00810077631461200 micron soft tip laser fiber11531115312025-08-29
00081007763051200 micron Soft Tip laser fiber11531115312025-05-20
00810077631454357 micron laser fiber11949119492025-04-30
00810077631447Stripper Scribe Tool113822025-04-11
00810077631430200 micron Excalibur DC laser fiber11952119522025-02-28
00810077631355300 micron laser fiber (KTP)11637116372024-08-09
00810077630594600 KTP Laser FiberOI-0600S-FT-000-AUR-1116392021-05-19
00810077631409300 micron laser fiber (KTP) with ScopeGuardian sheath119402024-09-24
00810077631393300 micron laser fiber (KTP) with ScopeGuardian sheath119402024-09-24
00810077631379300 micron laser fiber (KTP)119112024-09-06
00810077631294SmartScopeSU-200-RT119202024-03-22
00810077631300SmartScopeSU-365-RT119222024-03-22
00810077631317SmartScopeSU-550-RT119232024-03-22
00810077631324SmartScopeSU-1000-RT119242024-03-22
00810077631331SmartScopeSU-200-TRUE-RT119192024-03-22
00810077630969SmartScopeSU-200-RT119202024-03-22
00810077630976SmartScopeSU-365-RT119222024-03-22
00810077630983SmartScopeSU-550-RT119232024-03-22
00810077630990SmartScopeSU-1000-RT119242024-03-22
00810077631348SmartScopeSU-200-TRUE-RT119192024-03-22

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Primary DI, Brand, Company table
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06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851088019BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
08800020109446TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109453TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109460TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109477TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109484TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109491TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109507TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
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08800020109682Edge Guide TipJeisys Medical Inc.GEX2026-07-16
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08800020109712Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109729Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109989FootswitchJeisys Medical Inc.GEX2026-07-16
08800020109996FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110008FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110275SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110282SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110299SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16