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Found 6 results
510(k) Data Aggregation
K Number
K030959Device Name
BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100
Manufacturer
LASER PERIPHERALS LLC.
Date Cleared
2003-04-25
(29 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
LASER PERIPHERALS LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Laser Peripherals bare laser fiber is intended for use in laser surgical procedures for cutting, coagulating, or vaporizing in any soft tissue application for which compatible Nd: YAG, KTP and Diode lasers have been cleared.
Device Description
Laser Peripherals Bare Laser Fiber
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K Number
K992083Device Name
SCATTERFREE LATERAL EMITTING FIBER
Manufacturer
LASER PERIPHERALS LLC.
Date Cleared
1999-07-12
(21 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
LASER PERIPHERALS LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ScatterFree™ Lateral Emitting Fiber is intended for use in General, Urological, OB-GYN, Orthopedic and ENT laser surgical procedures for cutting, vaporizing or coagulating in any soft tissue application for which compatible Nd:YAG, KTP and Ho:YAG lasers have been cleared.
Device Description
ScatterFree™ Lateral Emitting Fiber
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K Number
K974229Device Name
LS-905 FIBERCHOICE ADAPTER SYSTEM
Manufacturer
LASER PERIPHERALS LLC.
Date Cleared
1998-02-10
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
LASER PERIPHERALS LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LS-905 FiberChoice™ Adapter System is indicated for use for non-standard laser output ports for lasers manufactured by Laserscope. The LS-905 FiberChoice™ Adapter System is designed to allow owners of Laserscope lasers to connect Laser Peripherals, Inc. 510(k) cleared laser fibers to their lasers. The adapter may be used in each surgical specialty or procedure along with Laser Peripherals laser fibers for which compatible Laserscope lasers have received regulatory clearance.
Device Description
Not Found
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K Number
K972272Device Name
LASER PERIPHERALS HOLMIUM BARE FIBERS
Manufacturer
LASER PERIPHERALS LLC.
Date Cleared
1997-07-29
(41 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
LASER PERIPHERALS LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Laser Peripherals Holmium Bare Fibers are indicated for a variety of surgical uses including open, laparoscopic or endoscopic ablation, coagulation, incision, excision, and vaporization. The delivery system may be used in each surgical specialty or procedure for which compatible Holmium and Nd: YAG lasers have received regulatory clearance.
Device Description
Not Found
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K Number
K961516Device Name
LASER PERIPHERALS INC. BARE FIBER
Manufacturer
LASER PERIPHERALS LLC.
Date Cleared
1996-06-27
(66 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
LASER PERIPHERALS LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K961079Device Name
LASER PERIPHERALS INC. SCATTERFREE FIBER
Manufacturer
LASER PERIPHERALS LLC.
Date Cleared
1996-05-22
(65 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
LASER PERIPHERALS LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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