21 CFR 886.5420 — Inserter/Remover Contact Lens
Ophthalmic (OP) · Part 886 Subpart F—Therapeutic Devices · § 886.5420
Identification
A contact lens inserter/remover is a handheld device intended to insert or remove contact lenses by surface adhesion or suction.
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 § 886.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KYE | Inserter/Remover Contact Lens | 1 | 12 |
