21 CFR 886.1350 — Photokeratoscope
Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1350
Identification
A keratoscope is an AC-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device includes the photokeratoscope which records corneal curvature by taking photographs of the cornea.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9. The battery-powered device is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HJA | Photokeratoscope | 1 | 5 | |
| HLQ | Keratoscope, Ac-Powered | 1 | 29 | |
| HLR | Keratoscope, Battery-Powered | 1 | 7 | |
| MMQ | Topographer, Corneal, Ac-Powered | 1 | 5 | |
| NOG | Topographer, Corneal, Battery Powered | 1 | 0 | |
| NOH | Photokeratoscope, Battery Powered | 1 | 0 |
