Search Results
Found 4 results
510(k) Data Aggregation
K Number
K973146Device Name
MENTOR SUPER ABSORBENT DRAPE
Manufacturer
MENTOR OPHTHALMICS, INC.
Date Cleared
1997-12-04
(104 days)
Product Code
KKX
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
MENTOR OPHTHALMICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mentor Absorbent Drape is used to absorb fluids during surgical procedures.
Device Description
The Mentor Absorbent Drape measures 29 X 35 inches and is comprised of layered absorbent material between a permeable spunbond layer and a non-permeable layer. The device is packaged sterile for single use only.
Ask a Question
K Number
K971538Device Name
MENTOR GEMINI HEMOSTATIC ERASER
Manufacturer
MENTOR OPHTHALMICS, INC.
Date Cleared
1997-07-14
(77 days)
Product Code
HQO
Regulation Number
886.4115Why did this record match?
Applicant Name (Manufacturer) :
MENTOR OPHTHALMICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mentor® Gemini™ Hemostatic Eraser™ is used to achieve episcleral and or intraocular hemostasis utilizing diathermy.
Device Description
The MENTOR® GEMINI™ HEMOSTATIC ERASER™ is a hand-held bipolar probe used for coagulation which consists of (a) a handle and (b) a disposable tip (electrode). The handle transfers RF energy to the disposable tip via a unique electrical contact system located in the internal cavity of the handle. After a single use, the Tip is intended to be disposed of in a safe and cost effective manner. The handle is intended to be used 1-50 times before discarding.
Ask a Question
K Number
K964312Device Name
MENTOR TONO-PEN 3
Manufacturer
MENTOR OPHTHALMICS, INC.
Date Cleared
1996-11-26
(28 days)
Product Code
HKY
Regulation Number
886.1930Why did this record match?
Applicant Name (Manufacturer) :
MENTOR OPHTHALMICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MENTOR TONO-PEN 3 is used to measure the intraocular pressure (IOP) during routine eye examination or when an increased IOP is suspected.
Device Description
The MENTOR TONO-PEN 3 is a precision electronic tonometer which measures intraocular pressure [IOP]. The body of the instrument is specially designed to fit comfortably in the user's hand, facilitating fast and accurate measurements.
TONO-PEN 3 contains an elemental silicon strain gage which converts intraocular pressure to an electrical signal. The pen displays each valid reading on a liquid crystal display [LCD]. When four valid readings are obtained, a mean IOP reading and an indication of reliability are shown on the LCD. The TONO-PEN 3 has a molded plastic tip which must be covered by a latex protective membrane. MENTOR Ocu-Film Tip covers are recommended.
Ask a Question
K Number
K960765Device Name
MENTOR ADVENT A/B SYSTEM
Manufacturer
MENTOR OPHTHALMICS, INC.
Date Cleared
1996-08-08
(164 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
MENTOR OPHTHALMICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MENTOR® Advent™ A/B System is a dual function ultrasonic ophthalmic imaging system. The A-scan is used to measure the axial length of the eye. The system includes various programs for calculating the optical power of the IOL to be implanted during cataract surgery. Anterior chamber depth and lens thickness of the eye are also measured and displayed. The B-scan is used to image the internal structure of the eye including the opaque media and posterior pathology for the purpose of diagnosing pathological or traumatic conditions in the eve.
Device Description
MENTOR® Advent™ A/B System is an easy to use ophthalmic ultrasonic system, offering capabilities and versatility for both A-scan and B-scan operations.
The A-Scan biometric unit of the Advent System has the following features: Operational modes - Automatic and Manual Probe alignment - LED fixation light and audio feedback Multiple eye categories - Normal, Aphakic, Cataractous, Dense Cataractous and Pseudophakic IOL calculations - programs include the latest in SRK, Holladay and Hoffer Q Patient storage - up to 16 patients, including right and left eye User interface - standard computer keyboard Display - 9" high resolution white phosphor CRT Accessories - printer, video output
The B-Scan imaging unit of the Advent System has the following features: Scanning - 50 degrees sector scan probe, allowing eye view from wide variety of angles
Normal mode - requires selection of parameters Windowed mode - allows user selectable scanning angle Controls - depth, gain, contrast and brightness Display - 9" high resolution white phosphor CRT User interface - standard computer keyboard
Accessories - camera, printer. VCR
MENTOR Advent™ System uses the following transducer operations and characteristics:
A-Scan: There is a single ultrasound mode where the transducer is pulsed at a repetition frequency of approximately 5 Hz. The transducer is a non-scanning crystal with a frequency of approximately 8 Mhz. This system uses the same ultrasound transducer as in the predicate device.
B-Scan: There are two ultrasound modes, Normal and Windowed. The transducer is a single crystal mechanical sector probe with a center frequency of 11 MHz. It is housed in an oil-filled sealed chamber. The transducer sweeps 8 frames/sec. Sweep angle is 50°, pulse repetition frequency is 5.5 KHz and there are 275 transmitted lines per scan. In the Windowed mode, the size and position of the user selected window affects the pulse rate and spacing of the pulse, and thus the radiated field. Ultrasonic power measurements reported later have been made in the worst case condition,
Ask a Question
Page 1 of 1