The following data is part of a premarket notification filed by Color Vision Technologies, Inc. with the FDA for Colormax Color Vision Enhancement Lenses.
| Device ID | K984219 |
| 510k Number | K984219 |
| Device Name: | COLORMAX COLOR VISION ENHANCEMENT LENSES |
| Classification | Lens, Prescription, Color Deficiency |
| Applicant | COLOR VISION TECHNOLOGIES, INC. 19726 COLIMA RD. SUITE 320 Rowland Heights, CA 91748 |
| Contact | Julie Kim |
| Correspondent | Julie Kim COLOR VISION TECHNOLOGIES, INC. 19726 COLIMA RD. SUITE 320 Rowland Heights, CA 91748 |
| Product Code | NAI |
| CFR Regulation Number | 886.5844 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-25 |
| Decision Date | 1999-11-18 |
| Summary: | summary |