HRO · Unit, Electrolysis, Ac-Powered, Ophthalmic
Ophthalmic · 21 CFR 886.4250 · Class 2
Overview
| Product Code | HRO |
|---|---|
| Device Name | Unit, Electrolysis, Ac-Powered, Ophthalmic |
| Regulation | 21 CFR 886.4250 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
Identification
An ophthalmic electrolysis unit is an AC-powered or battery-powered device intended to destroy ocular hair follicles by applying a galvanic electrical current.
Classification Rationale
(1) Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.(2) Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Special Controls
*Classification.* (1) Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.(2) Class II (special controls) for the AC-powered device. The AC-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Cleared Devices (0)
No cleared devices on record.
