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Tomography, Optical Coherence

Page Type
Product Code
Definition
Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.
Physical State
Computerized imaging device consisting of light sources and beam delivery and scanning optics.
Technical Method
Cross sectional tomograms of ocular structures are obtained using non-invasive, non-contact, low-coherence optical interferometry.
Target Area
Eye.
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
886.1570
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.1570 Ophthalmoscope

§ 886.1570 Ophthalmoscope.

(a) Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.

(b) Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 84 FR 71817, Dec. 30, 2019]

Tomography, Optical Coherence

Page Type
Product Code
Definition
Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.
Physical State
Computerized imaging device consisting of light sources and beam delivery and scanning optics.
Technical Method
Cross sectional tomograms of ocular structures are obtained using non-invasive, non-contact, low-coherence optical interferometry.
Target Area
Eye.
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
886.1570
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.1570 Ophthalmoscope

§ 886.1570 Ophthalmoscope.

(a) Identification. An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.

(b) Classification. Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 84 FR 71817, Dec. 30, 2019]