510(k) K012132
K012132 is an FDA 510(k) premarket notification submitted by Cantor & Nissel , Ltd. for the device "CHROMAGEN V3.0 READING AID SOFT CONTACT LENS". The FDA issued a decision of Substantially Equivalent on May 9, 2002. The device falls under product code NIC (Lens, Contact, For Reading Discomfort), a Class II device regulated under 21 CFR 886.5925. Cantor & Nissel , Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 2002
- Date Received
- July 9, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lens, Contact, For Reading Discomfort
- Device Class
- Class II
- Regulation Number
- 886.5925
- Review Panel
- OP
- Submission Type
This lens is indicated for daily wear for the correction of refractive ametropia in persons with non-diseased eyes. This lens may also be prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error.