COLORMAX COLOR VISION ENHANCEMENT LENSES
FDA 510(k) clearance K984219 · decided 1999-11-18
Clearance details
- K-number
- K984219
- Device name
- COLORMAX COLOR VISION ENHANCEMENT LENSES
- Applicant
- Color Vision Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-11-25
- Decision date
- 1999-11-18
- Days to decision
- 358 days
- Clearance type
- Traditional
- Product code
- NAI
- Device class
- 1
- Regulation number
- 886.5844
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Rowland Heights, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Color Vision Technologies
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.