Last synced on 30 September 2022 at 11:05 pm

Camera, Ophthalmic, Ac-Powered

Page Type
Product Code
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
886.1120
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 886.1120 Ophthalmic camera

§ 886.1120 Ophthalmic camera.

(a) Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

(b) Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

[55 FR 48441, Nov. 20, 1990, as amended at 84 FR 71817, Dec. 30, 2019]

Camera, Ophthalmic, Ac-Powered

Page Type
Product Code
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
886.1120
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 886.1120 Ophthalmic camera

§ 886.1120 Ophthalmic camera.

(a) Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

(b) Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

[55 FR 48441, Nov. 20, 1990, as amended at 84 FR 71817, Dec. 30, 2019]