Intraocular Lens
An Intraocular Lens (IOL) is a surgically implanted artificial lens placed within the eye, typically to replace the natural crystalline lens following cataract extraction, providing optical correction of aphakia or refractive error. This device is FDA Class 3 (highest risk), requiring Premarket Approval (PMA) to demonstrate reasonable assurance of safety and effectiveness prior to marketing. It carries product code HQL and is regulated under 21 CFR 886.3600, within the Ophthalmic medical specialty. It is classified as an implant.
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Basic Information
- Product Code
- HQL
- Device Class
- FDA class 3
- Regulation Number
- 886.3600
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 2
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K914311 | CHIROFLEX II LENS MICROSERT(TM) | Jan 27, 1992 | Substantially Equivalent | Chiron Ophthalmics |
| K913626 | SOFTRANS INJECTOR | Dec 18, 1991 | Substantially Equivalent | Staar Surgical Co. |
| K842892 | NIDEK DIGITAL KERATOMETER | Oct 05, 1984 | Substantially Equivalent | Nidek, Inc. |
| K842504 | AMER. MEDICAL OPTICS DIGITAL KERATO- | Oct 01, 1984 | Substantially Equivalent | American Medical Optics |
| K771933 | CILCO ANTERIOR CHAMBER LENS | Jan 26, 1978 | Substantially Equivalent | California Intraocular Lens |
FEI Numbers
This FDA classification entry is associated with 57 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 57 registration numbers. Click on an entry to view related FDA registrations.