Inserter/Remover Contact Lens
The Contact Lens Inserter/Remover is an ophthalmic device used to assist patients in safely placing and removing contact lenses from the eye, reducing the risk of corneal trauma or contamination during lens handling. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, with no premarket submission required. The product code is KYE, regulated under 21 CFR 886.5420, in the Ophthalmic medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- KYE
- Device Class
- FDA class 1
- Regulation Number
- 886.5420
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K872567 | SOFT CONTACT LENS REMOVER | Aug 10, 1987 | Substantially Equivalent | Magnivision, Inc. |
| K872591 | HARD CONTACT LENS REMOVER. ITEM #289 | Aug 04, 1987 | Substantially Equivalent | Magnivision, Inc. |
| K871130 | CONTACT LENS TWEEZERS | May 12, 1987 | Substantially Equivalent | S. M. C. Medi-Tech Corp. |
| K870072 | SUMMIT OPTICS CONTACT LENS REMOVER | Feb 12, 1987 | Substantially Equivalent | Dayton Mfg. Co. |
| K850984 | MARLIN SOFT LENS HANDLER | Sep 10, 1985 | Substantially Equivalent | Marlin Industries |
| K850983 | MARLIN SOFT LENS TWEEZER | Sep 10, 1985 | Substantially Equivalent | Marlin Industries |
| K830738 | LENSERT CONTACT LENS CLEANING & INSERT | Jun 10, 1983 | Substantially Equivalent | Jermyn Specialties of California |
| K830496 | DMV ANGLER | Mar 09, 1983 | Substantially Equivalent | Dmv Contact Lens Co. |
| K782140 | REMOVER, SOFT-SERT CONTACT LENS | Feb 12, 1979 | Substantially Equivalent | Mcmurray and Pendergost |
| K780931 | SOFT LENS INSERTER | Jun 28, 1978 | Substantially Equivalent | Soft-Sert |
| K780664 | SOFT LENS REMOVER/INSERTER/MANIPULATOR | May 17, 1978 | Substantially Equivalent | Dmv Contact Lens Co. |
| K780663 | CONTACT LENS REMOVER AND INSERTER | May 17, 1978 | Substantially Equivalent | Dmv Contact Lens Co. |
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.