NAIClass I
Lens, Prescription, Color Deficiency
21 CFR 886.5844 / Ophthalmic
NAI is the FDA product code for Lens, Prescription, Color Deficiency, a class I device type, regulated under 21 CFR 886.5844. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.
Classification record
- Product code
- NAI
- Device name
- Lens, Prescription, Color Deficiency
- Regulation
- 21 CFR 886.5844
- Device class
- Class I
- Review panel
- Ophthalmic
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 1
Clearances, product code NAI
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1999 | 1 |
Applicants with the most clearances
Product code NAI| Applicant | Clearances |
|---|---|
| Color Vision Technologies, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Danyang Rimesis Optical Glasses Co.,Ltd
- Enchroma Inc
- Eyepol Optical Technology (Xiamen) Co., Ltd.
- IRENE Corporation
- JH Optical Co., Ltd.
- Shih Min Glasses Co., Ltd.
- Tecnologia Sostenible y Responsable S.L.
- Tsingtao Relly Optics Co., Ltd
- Vision Dynamics, LLC
- Wal-Mart Optical Lab
- Wal-Mart Optical Lab #9065
- Walmart Optical Lab
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
