Search Results
Found 3 results
510(k) Data Aggregation
K Number
K222395Device Name
Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo
Manufacturer
Ellex Medical Pty Ltd
Date Cleared
2022-11-02
(86 days)
Product Code
HQF, HOF
Regulation Number
886.4390Why did this record match?
Applicant Name (Manufacturer) :
Ellex Medical Pty Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
In the YAG mode (Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo): -Iridotomy and iridectomy. -Posterior capsulotomy. -Posterior membranectomy.
In the SLT mode (Tango Neo, Tango Reflex Neo) : -Selective Laser Trabeculoplasty (SLT)
Device Description
These devices are slit lamp based surgical laser instruments designed for use by ophthalmologists in clinics or an outpatient facility in a hospital or surgery. These systems are used to perform both Photodisruption procedures such as posterior capsulotomies, iridotomies, posterior membranectomies in the photodisruptor (YAG mode) and Selective Laser Trabeculoplasty (SLT mode) for the treatment of chronic open angle glaucoma.
All these devices consist of the below main parts: Delivery Head, Microscope and Slit lamp Illumination, Console and Table Top, Joystick fire button, Total solution table, Display unit.
Ask a Question
K Number
K212630Device Name
Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo
Manufacturer
Ellex Medical Pty Ltd
Date Cleared
2021-12-16
(119 days)
Product Code
HQF, HOF
Regulation Number
886.4390Why did this record match?
Applicant Name (Manufacturer) :
Ellex Medical Pty Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
In the YAG mode (Tango, Ultra Q, Ultra Q Reflex, Tango Reflex): -Iridotomy and iridectomy. -Posterior capsulotomy. -Posterior membranectomy.
In the SLT mode (Tango, Solo, Tango Reflex): -Selective Laser Trabeculoplasty (SLT)
Device Description
These devices are slit lamp based surgical laser instruments designed for use by ophthalmologists in clinics or an outpatient facility in a hospital or surgery. These systems are used to perform both Photodisruption procedures such as posterior capsulotomies, iridotomies, posterior membranectomies in the photodisruptor (YAG mode) and Selective Laser Trabeculoplasty (SLT mode) for the treatment of chronic open angle glaucoma.
Ask a Question
K Number
K190786Device Name
Eye Prime
Manufacturer
Ellex Medical Pty Ltd.
Date Cleared
2019-04-11
(15 days)
Product Code
IYO, ITX
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
Ellex Medical Pty Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Eye Prime is intended for ophthalmic imaging when the following conditions are present or suspected:
•Cataracts
•Retinal Detachment (separation of the retina from the middle coat of the eyeball)
•Orbital Lesions
•Tumors
•Foreign Bodies
•Inflammation
•Vascular Irregularities
Device Description
The Eye Prime is a new, diagnostic ophthalmic ultrasound Track 1 device. Its function is to perform B-mode ultrasound scans. The system consists of 1) A console which supports 12 and 18MHz Posterior B scan probes and Anterior B- Scan. Ultrasound Bio-microscopy (UBM) probes with either 35 or 50MHz transducers. 2) A laptop which performs the image processing requirements of the system; provides the user interface for operating the device and viewing the resultant images. The laptop also provides data storage, export, archiving and networking for the device and includes the connection for footswitch.
Ask a Question
Page 1 of 1