KYE · Inserter/Remover Contact Lens
Ophthalmic · 21 CFR 886.5420 · Class 1
Overview
| Product Code | KYE |
|---|---|
| Device Name | Inserter/Remover Contact Lens |
| Regulation | 21 CFR 886.5420 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
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.
Cleared Devices (12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K872567 | SOFT CONTACT LENS REMOVER | Magnivision, Inc. | Aug 10, 1987 | SESE |
| K872591 | HARD CONTACT LENS REMOVER. ITEM #289 | Magnivision, Inc. | Aug 4, 1987 | SESE |
| K871130 | CONTACT LENS TWEEZERS | S. M. C. Medi-Tech Corp. | May 12, 1987 | SESE |
| K870072 | SUMMIT OPTICS CONTACT LENS REMOVER | Dayton Mfg. Co. | Feb 12, 1987 | SESE |
| K850984 | MARLIN SOFT LENS HANDLER | Marlin Industries | Sep 10, 1985 | SESE |
| K850983 | MARLIN SOFT LENS TWEEZER | Marlin Industries | Sep 10, 1985 | SESE |
| K830738 | LENSERT CONTACT LENS CLEANING & INSERT | Jermyn Specialties of California | Jun 10, 1983 | SESE |
| K830496 | DMV ANGLER | Dmv Contact Lens Co. | Mar 9, 1983 | SESE |
| K782140 | REMOVER, SOFT-SERT CONTACT LENS | Mcmurray and Pendergost | Feb 12, 1979 | SESE |
| K780931 | SOFT LENS INSERTER | Soft-Sert | Jun 28, 1978 | SESE |
| K780664 | SOFT LENS REMOVER/INSERTER/MANIPULATOR | Dmv Contact Lens Co. | May 17, 1978 | SESE |
| K780663 | CONTACT LENS REMOVER AND INSERTER | Dmv Contact Lens Co. | May 17, 1978 | SESE |
Top Applicants
- Dmv Contact Lens Co. — 3 clearances
- Marlin Industries — 2 clearances
- Magnivision, Inc. — 2 clearances
- Soft-Sert — 1 clearance
- S. M. C. Medi-Tech Corp. — 1 clearance
