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Found 3 results
510(k) Data Aggregation
K Number
K121570Device Name
AURIGA QI
Manufacturer
STARMEDTEC GMBH
Date Cleared
2013-01-16
(232 days)
Product Code
GEX, AUR
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
STARMEDTEC GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Auriga QI laser system including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialities including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery.
Device Description
The Auriga QI is a holmium laser system, which emits laser radiation with a wavelenath of approximately 2,1 um. Optical laser power is transferred via an optical application fiber. The indications are lithotripsy, dissection, ablation, resection and coagulation of tissue. The laser system consists of: laser system including control panel (user interface), foot switch, application fiber.
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K Number
K111475Device Name
AURIGA XL
Manufacturer
STARMEDTEC GMBH
Date Cleared
2011-09-28
(124 days)
Product Code
GEX, GRE
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
STARMEDTEC GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Auriga XL laser system including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialities including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery
Device Description
The Auriga XL is a holmium laser system, which emits laser radiation with a wavelength of approximately 2.1 um. The laser power transfers an optical application fiber. The indications are lithotripsy, dissection, ablation, resection and coagulation of tissue. The laser system consists of:
- laser system including control panel (user interface)
- foot switch
- application fiber
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K Number
K103654Device Name
VELA XL
Manufacturer
STARMEDTEC GMBH
Date Cleared
2011-04-06
(112 days)
Product Code
GEX, VEL
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
STARMEDTEC GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The vela® XL laser system including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft and hard tissue in medical specialities including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery.
Device Description
The vela® XL is thulium laser system, which emits laser radiation with a wavelength of approximately 1.9 µm. The laser power transfers an optical application fiber. The indications are dissection, ablation, resection and coagulation of tissue. The laser system consists of: - laser system including control panel (user interface) - foot switch - application fiber
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