21 CFR 886.1570 — Ophthalmoscope, Ac-Powered
Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1570
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HLI | Ophthalmoscope, Ac-Powered | 2 | 87 | |
| HLJ | Ophthalmoscope, Battery-Powered | 2 | 47 | |
| MSG | Ophthalmoscopes, Replacement Batteries, Hand-Held | 2 | 2 | |
| MYC | Ophthalmoscope, Laser, Scanning | 2 | 22 | 3rd Party |
| OBO | Tomography, Optical Coherence | 2 | 65 |
Special Controls
HLI — Ophthalmoscope, Ac-Powered
*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.
eCFR
HLJ — Ophthalmoscope, Battery-Powered
*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.
eCFR
MSG — Ophthalmoscopes, Replacement Batteries, Hand-Held
*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.
eCFR
MYC — Ophthalmoscope, Laser, Scanning
*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.
eCFR
OBO — Tomography, Optical Coherence
*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.
eCFR
