NCE · Injector, Capsular Tension Ring
Ophthalmic · 21 CFR 886.4300 · Class 1
Overview
| Product Code | NCE |
|---|---|
| Device Name | Injector, Capsular Tension Ring |
| Regulation | 21 CFR 886.4300 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
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.
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K042478 | CAPSULE TENSION RING INSERTER, MODEL 7-810 | Duckworth & Kent, Ltd. | Dec 28, 2004 | SESE |
| K011498 | EASY CONTROL MICRO INSERTER, MODEL ON385 | Ophtec USA, Inc. | Jul 9, 2001 | SESE |
| K001125 | GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING | Geuder GmbH | Oct 4, 2000 | SESE |
Top Applicants
- Ophtec USA, Inc. — 1 clearance
- Geuder GmbH — 1 clearance
- Duckworth & Kent, Ltd. — 1 clearance
