HQN · Conformer, Ophthalmic
Ophthalmic · 21 CFR 886.3130 · Class 2
Overview
| Product Code | HQN |
|---|---|
| Device Name | Conformer, Ophthalmic |
| Regulation | 21 CFR 886.3130 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
Identification
An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K972034 | MEDPOR OCULAR CONFORMER | Porex Surgical, Inc. | Jan 20, 1998 | SESE |
| K970319 | OCULAR CONFORMER | Xavier A. Guerra, Ocularist, Inc. | Jul 7, 1997 | SESE |
| K970318 | OCULAR CONFORMER | Southwest Artificial Eyes, Inc. | Jul 7, 1997 | SESE |
| K945110 | KOLBERG OPHTHALMIC CONFORMER | Kolberg Ocular Products, Inc. | Jan 13, 1995 | SESE |
| K921221 | STERILE/SINGLE USE SYMBLEPHARON RING | Storz Instrument Co. | Jul 17, 1992 | SESE |
| K921229 | STERILE/SINGLE USE OPHTHALMIC CONFORMERS | Storz Instrument Co. | Jun 9, 1992 | SESE |
| K772168 | MOLDEYE | Robert B. Scott Ocularists of Florida, Inc. | Nov 30, 1977 | SESE |
Top Applicants
- Storz Instrument Co. — 2 clearances
- Kolberg Ocular Products, Inc. — 1 clearance
- Porex Surgical, Inc. — 1 clearance
- Robert B. Scott Ocularists of Florida, Inc. — 1 clearance
- Southwest Artificial Eyes, Inc. — 1 clearance
