Systems of Sight Low Vision Eyeware
FDA 510(k) K854854 · Int'L Eye Care, Inc.
510(k) numberK854854
Submission
- Device name
- Systems of Sight Low Vision Eyeware
- Applicant
- Int'L Eye Care, Inc.
Rochester, NY, US - Received
- December 5, 1985
- Decision date
- February 4, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HOI – Spectacle, Magnifying
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.5840
- Specialty
- Ophthalmic
Other 510(k)s with product code HOI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K943613 | NilHOI · Traditional | Sing Wah International Enterprises , Ltd. | 09/21/1994SE |
| K930435 | Spectacle FramesHOI · Traditional | Venis DI A. Vendrame | 09/20/1993SE |
| K931328 | Pyramid Sunglasses/Pyramid Reading GlassesHOI · Traditional | Pyramid | 08/10/1993SE |
| K910329 | SunglassesHOI · Traditional | Cutler & Gross Sloan Optical , Ltd. | 03/12/1991SE |
| K844716 | Magnifying Spectacles W/Plastic LensesHOI · Traditional | Gazelle Corp. | 01/03/1985SE |
| K844038 | Visitec Magnifying SpectaclesHOI · Traditional | Visitec Co. | 11/29/1984SE |
| K842835 | Brillette ModelHOI · Traditional | Cillus Company, Inc. | 11/21/1984SE |
| K820732 | La Vel Lateral View Extension LensHOI · Traditional | Peter M. Tolliver | 05/03/1982SE |
| K813548 | Uvex Mini-SpecsHOI · Traditional | Bacou USA, Inc. and Uvex Safety, Inc. | 03/02/1982SE |
| K801733 | Fenzl ReticleHOI · Traditional | Robert E. Fenzl, M.D. | 09/16/1980SE |
Questions and answers
When was Systems of Sight Low Vision Eyeware cleared by the FDA?
Systems of Sight Low Vision Eyeware (K854854) received a 510(k) decision of Substantially Equivalent on February 4, 1986, 61 days after the submission was received.
What is the product code of K854854?
The FDA product code is HOI – Spectacle, Magnifying, a Class I (low risk) device regulated under 21 CFR 886.5840.