Eye Barrier
FDA 510(k) K863182 · O.R. Concepts, Inc.
510(k) numberK863182
Submission
- Device name
- Eye Barrier
- Applicant
- O.R. Concepts, Inc.
Roanoke, TX, US - Received
- August 19, 1986
- Decision date
- September 3, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HQZ – Frame, Spectacle
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.5842
- Specialty
- Ophthalmic
Other 510(k)s with product code HQZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K952597 | View Point, Dorion, Ruddy Project, Ultra Flex, Trillon, Bay Boy, Shield Ski, Sun…HQZ · Traditional | Point of View Optical Outlet, Inc. | 09/12/1995SE |
| K944313 | Spectacle FrameHQZ · Traditional | Sun Hing Optical Manufactory , Ltd. | 03/28/1995SE |
| K945770 | Optical FramesHQZ · Traditional | Ramada Optics, Inc. | 12/15/1994SE |
| K945392 | Spectacle FrameHQZ · Traditional | Seo Han Corp., Ltd. | 12/15/1994SE |
| K945176 | Spectacle Frame or Eyeglass FramesHQZ · Traditional | Optipia Trading Co. | 12/15/1994SE |
| K945350 | Frame, SpectaclesHQZ · Traditional | Taiwan Eva Industrial Co., Inc. | 12/13/1994SE |
| K945342 | MAG-1 Spectacle FrameHQZ · Traditional | Criss Optical Mfg. Co., Inc. | 11/28/1994SE |
| K945450 | Frame, SpectacleHQZ · Traditional | Kookje Apis Industrial Co. | 11/22/1994SE |
| K945340 | Spectacle Frames or Eyeglass FramesHQZ · Traditional | Mi Mun Corp. | 11/22/1994SE |
| K945323 | Spectacle FrameHQZ · Traditional | M.Y. Vision Corp. | 11/22/1994SE |
More from M.Y. Vision Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K941337 | Flowgun Electrocautery ProbesGEI · Traditional | 08/17/1994SE |
| K935971 | Flowgun Electrocautery ProbesGEI · Traditional | 05/16/1994SE |
| K935970 | Flowgun Electrocautery Probe HandleGEI · Traditional | 05/16/1994SE |
| K935645 | Flowgun Reusable Irrigation ProbesGCJ · Traditional | 03/07/1994SE |
| K926242 | Orc Endoscopic Monopolar Electrosurgical ProbeGEI · Traditional | 10/15/1993SE |
| K922244 | Insufflator Tubing/Filter KitHIF · Traditional | 09/24/1993SE |
| K922197 | Insufflator Tubing KitHIG · Traditional | 09/24/1993SE |
| K932449 | Dr. FogOCT · Traditional | 08/11/1993SE |
| K925147 | Orc 10.0MM Suction ProbeGCJ · Traditional | 06/25/1993SE |
| K925024 | Orc Tappered Irrigating ProbeGCY · Traditional | 05/21/1993SE |
Questions and answers
When was Eye Barrier cleared by the FDA?
Eye Barrier (K863182) received a 510(k) decision of Substantially Equivalent on September 3, 1986, 15 days after the submission was received.
What is the product code of K863182?
The FDA product code is HQZ – Frame, Spectacle, a Class I (low risk) device regulated under 21 CFR 886.5842.