Conformer, Ophthalmic
An Ophthalmic Conformer is a smooth, curved device placed in the conjunctival fornices of the eye socket following enucleation, evisceration, or eyelid surgery to maintain the shape of the socket, prevent fornix contraction, and preserve space for fitting an ocular prosthesis. This device is FDA Class 2 (moderate risk), subject to general controls and special controls without requiring premarket notification in all cases. It carries product code HQN and is regulated under 21 CFR 886.3130, within the Ophthalmic medical specialty.
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Basic Information
- Product Code
- HQN
- Device Class
- FDA class 2
- Regulation Number
- 886.3130
- 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 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K972034 | MEDPOR OCULAR CONFORMER | Jan 20, 1998 | Substantially Equivalent | Porex Surgical, Inc. |
| K970319 | OCULAR CONFORMER | Jul 07, 1997 | Substantially Equivalent | Xavier A. Guerra, Ocularist, Inc. |
| K970318 | OCULAR CONFORMER | Jul 07, 1997 | Substantially Equivalent | Southwest Artificial Eyes, Inc. |
| K945110 | KOLBERG OPHTHALMIC CONFORMER | Jan 13, 1995 | Substantially Equivalent | Kolberg Ocular Products, Inc. |
| K921221 | STERILE/SINGLE USE SYMBLEPHARON RING | Jul 17, 1992 | Substantially Equivalent | Storz Instrument Co. |
| K921229 | STERILE/SINGLE USE OPHTHALMIC CONFORMERS | Jun 09, 1992 | Substantially Equivalent | Storz Instrument Co. |
| K772168 | MOLDEYE | Nov 30, 1977 | Substantially Equivalent | Robert B. Scott Ocularists of Florida, Inc. |
FEI Numbers
This FDA classification entry is associated with 33 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 33 registration numbers. Click on an entry to view related FDA registrations.