Product code HQN
- Device name
- Conformer, Ophthalmic
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.3130
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972034 | MEDPOR OCULAR CONFORMER | Porex Surgical, Inc. | 1998-01-20 |
| K970318 | OCULAR CONFORMER | Southwest Artificial Eyes, Inc. | 1997-07-07 |
| K970319 | OCULAR CONFORMER | Xavier A. Guerra, Ocularist, Inc. | 1997-07-07 |
| K945110 | KOLBERG OPHTHALMIC CONFORMER | Kolberg Ocular Products, Inc. | 1995-01-13 |
| K921221 | STERILE/SINGLE USE SYMBLEPHARON RING | Storz Instrument Co. | 1992-07-17 |
| K921229 | STERILE/SINGLE USE OPHTHALMIC CONFORMERS | Storz Instrument Co. | 1992-06-09 |
| K772168 | MOLDEYE | Robert B. Scott Ocularists of Florida, Inc. | 1977-11-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| CONFV2628 | Soper Brothers Custom | Soper Brothers, Incorporated | 2026-03-03 |
| 00860015162823 | Dallas Eye Prosthetics | Dallas Eye Prosthetics | 2025-12-23 |
| G568V2628 | Ophthalmic Conformer | THOMPSON OCULAR PROSTHETICS, INC. | 2025-03-10 |
| B796V2628 | Ophthalmic Conformer | MIDWEST EYE LABORATORIES, INC. | 2024-03-28 |
| G519V2628 | Ophthalmic Conformer | Midwest Eye Laboratories Sioux Falls, LLC | 2024-03-10 |
| G290V2628 | Ophthalmic Conformer | Midwest Eye Laboratories Woodbury, LLC | 2024-02-20 |
| G542V26280 | Ophthalmic Conformer | THE EYE CONCERN, INC. | 2024-01-10 |
| G521V2628 | Ophthalmic Conformer | Legrand Associates | 2023-10-18 |
| 00854428006218 | Lucite Conformer | Jardon Eye Prosthetics, Inc. | 2023-06-26 |
| 00854428006201 | Lucite Conformer | Jardon Eye Prosthetics, Inc. | 2023-06-26 |
| 00854428006195 | Lucite Conformer | Jardon Eye Prosthetics, Inc. | 2023-06-26 |
| 00854428006348 | Silicone Conformer | Jardon Eye Prosthetics, Inc. | 2023-06-26 |
| 00854428006355 | Silicone Conformer | Jardon Eye Prosthetics, Inc. | 2023-06-26 |
| 13700773724908 | SYMBLEPHARON RING 25 MM | FCI S A S FCI 20 22 | 2021-05-30 |
| 13700773724915 | SYMBLEPHARON RING 20 MM | FCI S A S FCI 20 22 | 2021-05-30 |
| 13700773724922 | SYMBLEPHARON RING 22 MM | FCI S A S FCI 20 22 | 2021-05-30 |
| 03760087122589 | SILICONE CONFORMER (FLEXIBLE) | FCI S A S FCI 20 22 | 2021-05-30 |
| 10697660002368 | Symblepharon Ring Conformer Medium | Oculo-Plastik Inc | 2019-10-23 |
| 10697660002344 | Symblepharon Ring Conformer Small | Oculo-Plastik Inc | 2019-10-23 |
| 10697660001194 | Bilateral Conformer 16 Regular | Oculo-Plastik Inc | 2019-10-21 |
| 10697660001132 | Bilateral Conformer 18 Small | Oculo-Plastik Inc | 2019-10-21 |
| 10697660001019 | Bilateral Conformer 22 Small | Oculo-Plastik Inc | 2019-10-18 |
| 90697660001077 | Bilateral Conformer 22 Regular With Holes, In Bulk | Oculo-Plastik Inc | 2019-10-18 |
| 90697660001046 | Bilateral Conformer 22 Small, In Bulk | Oculo-Plastik Inc | 2019-10-18 |
| 90697660001039 | Bilateral Conformer 22 Small With Holes, Bulk | Oculo-Plastik Inc | 2019-10-18 |
| 10697660001064 | Bilateral Conformer 22 Regular With Holes | Oculo-Plastik Inc | 2019-10-18 |
| 10697660001057 | Bilateral Conformer 22 Regular | Oculo-Plastik Inc | 2019-10-18 |
| M87221416V95 | Symblepharon Ring Conformer Large, In Bulk | Oculo-Plastik Inc | 2016-10-16 |
| M87219124V98 | Bilateral Conformer 16 Regular, In Bulk | Oculo-Plastik Inc | 2016-10-16 |
| 00854066006120 | Bio-Eye® | INTEGRATED ORBITAL IMPLANTS INC | 2015-12-01 |