HRB · Microscope, Operating, Non-Electric, Ophthalmic
General, Plastic Surgery · 21 CFR 878.4700 · Class 1
Overview
| Product Code | HRB |
|---|---|
| Device Name | Microscope, Operating, Non-Electric, Ophthalmic |
| Regulation | 21 CFR 878.4700 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.
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 § 878.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
