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510(k) Data Aggregation
K Number
K233398Device Name
Faros Surgical System
Manufacturer
Oertli Instrumente AG
Date Cleared
2024-06-27
(268 days)
Product Code
HQC, GEI, HQE
Regulation Number
886.4670Why did this record match?
Applicant Name (Manufacturer) :
Oertli Instrumente AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Faros is a surgery system used by ophthalmologists during cataract surgery. It is designed for use in anterior segment procedures that require simultaneous lens fragmentation, irrigation, as well as ancillary functions such as vitreous cutting along with bipolar diathermy.
Faros is used for these surgical interventions in the anterior eye segment:
- Irrigation and aspiration (I/Afunction)
- Ultrasound phaco (PHACO function)
- Biopolar diathermy for hemostasis and coaptation of the conjunctiva (DIA function)
- Bipolar diathermic capsulotomy (CAPS function)
- Operation of a vitrectomy instrument (VIT function)
The device may only be used with the instruments recommended and supplied by Oertli.
Device Description
The Faros Surgery System is designed for use in anterior segment eye surgery, primarily for removal of cataractous lenses. The system generates high-frequency ultrasound to emulsify the eye's natural lens, which is then aspirated using fluidics. The system also includes functions for bipolar diathermy (for hemostasis, conjunctival coaptation, and capsulotomy), as well as for anterior vitrectomy, a procedure associated with cataract surgery.
The Faros Surgery System consists of a main unit (an AC-powered tower-like device with a control panel governing surgical functions, and ports to connect surgical instruments), with a mounted infusion pole and a foot pedal used by the surgeon to control system functions. An irrigation tubing system is mounted onto the main unit. Surgical handpieces connected to the main unit are used to perform irrigation and aspiration, ultrasound phacoemulsification, bipolar diathermy, bipolar diathermic capsulotomy, and anterior vitrectomy functions.
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K Number
K133562Device Name
CATARHEX 3
Manufacturer
OERTLI INSTRUMENTE AG
Date Cleared
2014-08-12
(265 days)
Product Code
HQC, GEI, HQE
Regulation Number
886.4670Why did this record match?
Applicant Name (Manufacturer) :
OERTLI INSTRUMENTE AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CataRhex 3 is used for surgical interventions in the anterior eye segment.
- Irrigation and aspiration (I/A function)
- Ultrasound phaco (PHACO function)
- Bipolar diathermy for hemostasis and welding of the conjunctiva (DIA function)
- Diathermic capsulotomy (CAPS function)
- . Operation of a vitrectomy instrument (VIT function)
The device may only be used with instruments recommended and supplied by Oertli Instrumente AG.
Device Description
The CataRhex 3 is medical electrical equipment to be used during eye surgery and is intended for ophthalmic anterior segment surgery.
It provides capabilities for phacoemulsification, phacofragmentation, diathermy coagulation, irrigation/ aspiration, vitrectomy and capsulotomy. The equipment has a display and buttons for selecting and activating the functions. With the equipment a footswitch is delivered for control by the surgeon.
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