21 CFR 886.1860 — Stand, Instrument, Ac-Powered, Ophthalmic
Ophthalmic (OP) · Part 886 Subpart B—Diagnostic Devices · § 886.1860
Identification
An ophthalmic instrument stand is an AC-powered or nonpowered device intended to store ophthalmic instruments in a readily accessible position.
Classification Rationale
Class I (general controls). The AC-powered device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The battery-powered 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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HMF | Stand, Instrument, Ac-Powered, Ophthalmic | 1 | 15 | |
| HMG | Stand, Instrument, Ophthalmic, Non-Powered | 1 | 4 | |
| HRE | Cabinet, Instrument, Ac-Powered, Ophthalmic | 1 | 0 | |
| NOI | Stand, Instrument, Ophthalmic, Battery Powered | 1 | 0 |
