Clearance Summary
COLORMAX COLOR VISION ENHANCEMENT LENSES received FDA 510(k) clearance under submission number K984219, sponsored by Color Vision Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1999-11-18.
- Submission: K984219
- Applicant / Sponsor: Color Vision Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5844
- Decision date: 1999-11-18
Classification & Regulation
This clearance is catalogued under FDA product code NAI and 21 CFR 886.5844, within the Ophthalmic review panel as a Class I device.