HKF · Mirror, Headband, Ophthalmic
Ophthalmic · 21 CFR 886.1500 · Class 1
Overview
| Product Code | HKF |
|---|---|
| Device Name | Mirror, Headband, Ophthalmic |
| Regulation | 21 CFR 886.1500 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
A headband mirror is a device intended to be strapped to the head of the user to reflect light for use in examination of the eye.
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 the limitations in § 886.9. The device is also 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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
