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510(k) Data Aggregation
K Number
K961560Device Name
ECLIPSE 2000
Manufacturer
Date Cleared
1997-01-27
(291 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CARDIOGENES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Eclipse 2000™ is intended for use in general surgery, including thoracic and abdominal surgeries. This includes the incision, excision, vaporization or coagulation of soft tissue and firm cartilage:
- . cholecystectomy
- lysis of adhesions .
- herniorrhaphy .
- sessile polyps of the intestine and colon .
- hemorrhoidectomy .
- condyloma .
- appendectomy ●
Device Description
The Eclipse Model 2000™ laser system is designed to be easy to operate and userfriendly. It features a security keyswitch and simple one-button start-up. Energy output is controlled by the Power thumbwheel adjustment. Energy is delivered through the Eclipse delivery system only when:
- 1) the laser is in Ready mode,
- 2) the Foot Pedal is depressed, and
- 3) the delivery system is properly installed in the laser aperture.
A variety of disposable fiber optic delivery systems in a range of sizes, designs and configurations is available from Eclipse. A fiber optic delivery system must be used to delivery laser energy to the treatment site.
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K Number
K955006Device Name
ECLIPSE 2100
Manufacturer
Date Cleared
1996-01-17
(77 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CARDIOGENES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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