Search Results
Found 3 results
510(k) Data Aggregation
K Number
K220090Device Name
Visibly Digital Acuity Product
Manufacturer
Visibly, Inc.
Date Cleared
2022-08-12
(213 days)
Product Code
QTO, OTO
Regulation Number
886.1150Why did this record match?
Search-Everything :
Matched: '886.1150'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Visibly Digital Acuity Product (VDAP) is a web-based, self-quided software application intended for use by adults, ages 22 to 40, who have the capability to perform a self-test at home, to aid in the evaluation of visual acuity with or without correction. The software allows users to view and respond to displayed optotypes and uses the responses to categorize a patient's visual acuity into one of two categories, with an individual output for each eye:
- . TRUE - visual acuity that is consistent with normal vision
- FALSE visual acuity that is not consistent with normal vision .
The Visibly Digital Acuity Product recommendations are intended to be supportive recommendations that will be used by an eye care provider, along with the patient's medical history and profile, prior corrective evewear prescriptions, and subjective vision data. The Visibly Digital Acuity Product does not provide screening or diagnosis of eye health or other disease, nor is it intended to replace an in-person eye exam.
Device Description
The Visibly Digital Acuity Product is a web-based, software application intended for use by adults, at home, to aid in the evaluation of visual acuity with or without correction. The standalone software application allows the user to interface with the software via a web browser on two internet-enabled devices:
- A computer screen (the Display) which displays optotypes. O
- A touchscreen mobile device (the Remote) which operates as a remote control and o interface for the user to respond to prompts related to the optotypes appearing on the Display while standing 10 feet away.
The software allows users to view and respond to displayed optotypes and uses the responses to categorize a user's vision acuity into one of two buckets: (1) TRUE - visual acuity that is consistent with normal vision (2) FALSE - visual acuity that is not consistent with normal vision.
Ask a Question
K Number
K100095Device Name
CENTRAL VISION ANALYZER MODEL 1000
Manufacturer
VIMETRICS,LLC.
Date Cleared
2010-05-10
(117 days)
Product Code
HOX
Regulation Number
886.1150Why did this record match?
Search-Everything :
Matched: '886.1150'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CVA-1000 is intended for use under the direct supervision of an ophthalmologist or optometrist in the measurement of vision at fixation in one or both eyes, with or without optical correction.
Device Description
The CVA-1000 instrument is a standalone device consisting of a computer processing unit with data storage, two LCD monitors, a physician viewed monitor and a patient viewed monitor, and connected keyboard and mouse for physician interaction with a response pad for patient interaction. The instrument provides an evaluation of vision at fixation of one or both eyes under different conditions of contrast and lighting assisting the ophthalmologist or optometrist in evaluating the effects of prescribed refractive instruments such as spectacles or contact lenses and of pharmaceutical treatment or surgical procedures on the central vision of one or both eyes.
The instrument may be used in either of two methods of operation: Chart Panel or Interactive Central Vision Panel.
Ask a Question
K Number
K031831Device Name
TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM
Manufacturer
TOPCON MEDICAL SYSTEMS, INC.
Date Cleared
2003-12-19
(189 days)
Product Code
HKO, HKN, HOX
Regulation Number
886.1760Why did this record match?
Search-Everything :
Matched: '886.1150'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Topcon Model BV-1000 Automated Subjective Refraction System provides sphere, cylinder, and axis measurements of the eye. The BV-1000 assists the eyecare professional in evaluating pre and post operative eye procedures and is used as an aid in prescribing eyeglasses and contact lenses.
Device Description
The Topcon Model BV-1000 is a safe and effective instrument. In essence, it is a combination of three Class I devices:
1) Ophthalmic Refractometer ... an AC-powered device that consist of a fixation system, a measurement and recording system and an alignment system.
2) Visual Acuity Chart ... a device, with a Landolt "C" chart in graduated sizes to test visual acuity
3) Onthalmic Motorized Refractor ... a device that incorporates a set of lenses of various dioptric powers intended to measure the refractive power of the eyc.
The BV-1000 is designed to perform binocular, simultaneous auto-refraction. It incorporates subjective refinement steps after the objective measurements have been obtained. The BV-1000 reduces the amount of time that eyecare professionals need to spend in refracting their patients as a substantial portion of the traditional refraction can be accomplished in the "pre test" room.
Ask a Question
Page 1 of 1