Last synced on 25 November 2022 at 11:04 pm

Intraocular, Pressure Measuring Device

Page Type
Product Code
Definition
Manual or ac powered device intended to measure intraocular pressure. Intended for use in the diagnosis of glaucoma.
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
PMA
Device Classification
Class 3
Regulation Number
886.4280
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.4280 Intraocular pressure measuring device

§ 886.4280 Intraocular pressure measuring device.

(a) Identification. An intraocular pressure measuring device is a manual or AC-powered device intended to measure intraocular pressure. Also included are any devices found by FDA to be substantially equivalent to such devices. Accessories for the device may include calibrators or recorders. The device is intended for use in the diagnosis of glaucoma.

(b) Classification. Class III.

(c) Date PMA or notice of completion of PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 886.3.

Intraocular, Pressure Measuring Device

Page Type
Product Code
Definition
Manual or ac powered device intended to measure intraocular pressure. Intended for use in the diagnosis of glaucoma.
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
PMA
Device Classification
Class 3
Regulation Number
886.4280
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.4280 Intraocular pressure measuring device

§ 886.4280 Intraocular pressure measuring device.

(a) Identification. An intraocular pressure measuring device is a manual or AC-powered device intended to measure intraocular pressure. Also included are any devices found by FDA to be substantially equivalent to such devices. Accessories for the device may include calibrators or recorders. The device is intended for use in the diagnosis of glaucoma.

(b) Classification. Class III.

(c) Date PMA or notice of completion of PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 886.3.