21 CFR 886.4300 — Lens, Guide, Intraocular
Ophthalmic (OP) · Part 886 Subpart E—Surgical Devices · § 886.4300
Identification
An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.
Classification Rationale
Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KYB | Lens, Guide, Intraocular | 1 | 39 | |
| MSS | Folders And Injectors, Intraocular Lens (Iol) | 1 | 62 | 3rd Party |
| NCE | Injector, Capsular Tension Ring | 1 | 3 | 3rd Party |
| OTZ | Graft Insertion Instrument For Endothelial Keratoplasty | 1 | 5 | |
| QQQ | Guide And Positioner, Ophthalmic Drug Delivery Device | 1 | 0 |
