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Found 8 results
510(k) Data Aggregation
K Number
K132975Device Name
SPHINX JR
Manufacturer
ALLMED SYSTEMS INC.
Date Cleared
2014-03-18
(176 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ALLMED SYSTEMS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sphinx Jr. laser system is intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gasteroenterology, Arthroscopy, Discetomy Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.
Device Description
The Sphinx Jr. system is a surgical laser system operating at a wavelength of 2.1 micron. The purpose of the laser is the ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery and surgical applications in aqueous media and non aqueous medium. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a handpiece endoscopic surgical instrument or similar approved device. It consists of: Laser Console with Internal Computer Control Panel and Display Operating Software Fiber port Footswitch
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K Number
K110941Device Name
REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200
Manufacturer
ALLMED SYSTEMS INC.
Date Cleared
2013-02-19
(687 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ALLMED SYSTEMS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RevoLix Jr 30, RevoLix Jr 50, RevoLix 160 and RevoLix 200 laser systems and their fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery. and Arthroscopy
Device Description
The RevoLix Family of diode pump solid state ( that include the RevoLix Jr 30, RevoLix Jr 50, RevoLix 160 and RevoLix 200) are part of a family of surgical laser systems operating at a wavelength of 2.01 micron. The purpose of these lasers is to ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery, laparoscopic surgical applications and procedures in an aqueous and non-aqueous media. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a hand piece. endoscopic or laparoscopic surgical instrument. It consists of: Laser Console with Internal Computer Control Panel and Display A fiber optic delivery system Footswitch
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K Number
K070924Device Name
FLEXGUARD
Manufacturer
ALLMED SYSTEMS INC.
Date Cleared
2007-06-21
(79 days)
Product Code
GEX, FED
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ALLMED SYSTEMS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FlexGuard Family of sheath's are intended for use in surgical procedures using flexible scopes and other approved flexible or rigid fiber optic delivery devices, to protect the working channel from damage when a laser fiber is introduced and also to provide irrigation to the surgical site when used for incision, ablation, vaporization and coagulation of soft tissue with any approved laser with a wavelength from 532nm to 2100nm in medical specialties including: Urology, Gasteroenterology, Thoracic, Head and Neck, Pulmonary, Gynecology, ENT and General Surgery
Device Description
The FlexGuard is a family of flexible sheaths that are used to protect the working channel of a flexible scope or surgical device from mechanical damage when the laser fiber is introduced into the working channel. The tip of the FlexGuard is allowed to protrude approx 3mm beyond the laser fiber, this assembly is then inserted into the working channel of the scope. The FlexGuard Family is designed to work with a range of laser fibers from 200 micron to 600 micron diameter. It consists of: Flexible Sheath Fiber clamp/Yee piece
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K Number
K070466Device Name
REVOLIX DUO LASER SYSTEM
Manufacturer
ALLMED SYSTEMS INC.
Date Cleared
2007-04-17
(60 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ALLMED SYSTEMS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Revolix Duo continuous wave 2.01 micron laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gasteroenterology, Arthroscopy, Discetomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.
The Revolix Duo pulsed Holmium 2.1 micron laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft and hard tissue in use in medical specialties including: Urnlogy, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discetomy Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.
Device Description
The RevoLix Duo is a combination of a diode pump solid state laser operating at a wavelength of 2.01 micron and a pulsed flashlamp Holmium laser operating at 2.1 microns. The purpose of the laser is the ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery and surgical applications in aqueous media. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a handpiece or endoscopic surgical instrument. It consists of: Laser Console with Internal Computer Control Panel and Display A fiber optic delivery system Footswitch
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K Number
K070476Device Name
REVOLIX 120
Manufacturer
ALLMED SYSTEMS INC.
Date Cleared
2007-03-26
(34 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ALLMED SYSTEMS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Revolix 120 laser systems and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery and Arthroscopy
Device Description
The RevoLix 120 laser system is diode pump solid state surgical laser system operating at a wavelength of 2.01 micron. The purpose of the laser is the ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery, laparoscopic and surgical applications in aqueous media. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a handpiece or endoscopic/laparoscopic surgical instrument. It consists of: Laser Console with Internal Computer Control Panel and Display A fiber optic delivery system Footswitch
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K Number
K051167Device Name
REVOLIX AND REVOLIX JR
Manufacturer
ALLMED SYSTEMS INC.
Date Cleared
2005-06-01
(27 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ALLMED SYSTEMS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Revolix and RevoLix Jr laser systems and its fiber optic delivery system are intended for used in surgical procedures and experience coagulation and hemostasis of soft including excision, resection, abiation, raponiation, valuation, varian and tissue in use in medical specialites inoldung: Orelegy, Central Surgery, General Surgery.and Arthroscopy
Device Description
The RevoLix and RevoLix Jr are diode pump solid state surgical laser system operating at a wavelength of 2.01 micron. The purpose of the laser is the ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery, laparoscopic and surgical applications in aqueous media. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a handpiece or endoscopic/laparoscopic surgical instrument.
It consists of:
Laser Console with Internal Computer Control Panel and Display A fiber optic delivery system Footswitch
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K Number
K033437Device Name
SPHINX LASER SYSTEMS
Manufacturer
ALLMED SYSTEMS INC.
Date Cleared
2004-01-20
(84 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ALLMED SYSTEMS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sphinx laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gasteroenterology, Arthroscopy, Discetomy Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.
Device Description
The Sphinx system is a surgical laser system operating at a wavelength of 2.1 micron. The purpose of the laser is the ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery and surgical applications in aqueous media. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a handpiece or endoscopic surgical instrument. It consists of: Laser Console with Internal Computer Control Panel and Display A fiber optic delivery system Footswitch
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K Number
K033423Device Name
REVOLIX LASER SYSTEMS
Manufacturer
ALLMED SYSTEMS INC.
Date Cleared
2004-01-15
(80 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
ALLMED SYSTEMS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Revolix laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialities including: Urology, Gasteroenterlogy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.
Device Description
The RevoLix diode pump solid state is a surgical laser system operating at a wavelength of 2.0 micron. The purpose of the laser is the ablation, coagulation, and hemostasis of soft tissue. The laser is designed for open surgery and surgical applications in aqueous media. The laser power is delivered via a fiber optic delivery system and this is guided by a handpiece or endoscopic surgical instrument. It consists of Laser Console with Internal Computer Control Panel and Display, A fiber optic delivery system, Footswitch.
Ask a Question
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