Last synced on 25 November 2022 at 11:04 pm

Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)

Page Type
Product Code
Definition
Pmma diagnostic contact lens ophthalmodynamometer is intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis of intraocular abnormalities. The device is indicated for examination of the ocular fundus, vitreous and retinal structures, while manually applying force to the eye with the contact lens. The device measures and displays the amount of force that is applied to the eye.
Physical State
The contact lens consists of a curved shell of acrylic plastic (PMMA), which is adapted with electronic sensors for measurement of pressure applied to the eye. The pressure values are displayed on a LCD display.
Technical Method
The examination PMMA contact lens is adapted with electronic sensors for measurement of pressure applied to the eye. The pressure values are displayed on a LCD display.
Target Area
Eye
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
886.1385
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens

§ 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.

(a) Identification. A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.

(b) Classification. Class II.

Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)

Page Type
Product Code
Definition
Pmma diagnostic contact lens ophthalmodynamometer is intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis of intraocular abnormalities. The device is indicated for examination of the ocular fundus, vitreous and retinal structures, while manually applying force to the eye with the contact lens. The device measures and displays the amount of force that is applied to the eye.
Physical State
The contact lens consists of a curved shell of acrylic plastic (PMMA), which is adapted with electronic sensors for measurement of pressure applied to the eye. The pressure values are displayed on a LCD display.
Technical Method
The examination PMMA contact lens is adapted with electronic sensors for measurement of pressure applied to the eye. The pressure values are displayed on a LCD display.
Target Area
Eye
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
886.1385
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens

§ 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.

(a) Identification. A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.

(b) Classification. Class II.