OPHTHASONIC A/P III
Device Facts
| Record ID | K903666 |
|---|---|
| Device Name | OPHTHASONIC A/P III |
| Applicant | Teknar, Inc. |
| Product Code | HPY · Ophthalmic |
| Decision Date | Nov 19, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.4250 |
| Device Class | Class 1 |
Regulatory Classification
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.
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.
