Last synced on 2 December 2022 at 11:04 pm

Unit, Beta, Radiation, Ophthalmic

Page Type
Product Code
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
886.5100
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 886.5100 Ophthalmic beta radiation source

§ 886.5100 Ophthalmic beta radiation source.

(a) Identification. An ophthalmic beta radiation source is a device intended to apply superficial radiation to benign and malignant ocular growths.

(b) Classification. Class II.

Unit, Beta, Radiation, Ophthalmic

Page Type
Product Code
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
886.5100
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 886.5100 Ophthalmic beta radiation source

§ 886.5100 Ophthalmic beta radiation source.

(a) Identification. An ophthalmic beta radiation source is a device intended to apply superficial radiation to benign and malignant ocular growths.

(b) Classification. Class II.