HPY · Unit, Electrolysis, Battery-Powered, Ophthalmic
Ophthalmic · 21 CFR 886.4250 · Class 1
Overview
| Product Code | HPY |
|---|---|
| Device Name | Unit, Electrolysis, Battery-Powered, Ophthalmic |
| Regulation | 21 CFR 886.4250 |
| Device Class | Class 1 |
| 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 (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K903666 | OPHTHASONIC A/P III | Teknar, Inc. | Nov 19, 1990 | SESE |
Top Applicants
- Teknar, Inc. — 1 clearance
