510(k) K984219
K984219 is an FDA 510(k) premarket notification submitted by Color Vision Technologies, Inc. for the device "COLORMAX COLOR VISION ENHANCEMENT LENSES". The FDA issued a decision of Substantially Equivalent on November 18, 1999. The device falls under product code NAI (Lens, Prescription, Color Deficiency), a Class I device regulated under 21 CFR 886.5844.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 18, 1999
- Date Received
- November 25, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lens, Prescription, Color Deficiency
- Device Class
- Class I
- Regulation Number
- 886.5844
- Review Panel
- OP
- Submission Type