Last synced on 27 January 2023 at 11:04 pm

Lens, Contact, Polymethylmethacrylate, Diagnostic

Page Type
Product Code
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
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.

Lens, Contact, Polymethylmethacrylate, Diagnostic

Page Type
Product Code
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
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.