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510(k) K022373

CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS by Cantor & Nissel , Ltd. — Product Code NJH

K022373 is an FDA 510(k) premarket notification submitted by Cantor & Nissel , Ltd. for the device "CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS". The FDA issued a decision of Substantially Equivalent on October 7, 2002. The device falls under product code NJH (Lens, Spectacle (Prescription), For Reading Discomfort), a Class I device regulated under 21 CFR 886.5844. Cantor & Nissel , Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2002
Date Received
July 22, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Spectacle (Prescription), For Reading Discomfort
Device Class
Class I
Regulation Number
886.5844
Review Panel
OP
Submission Type

Colored spectacle lenses 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.

Other clearances by Cantor & Nissel , Ltd.

  • K041700 — CANTOR & NISSEL HAND PAINTED PROSTHETIC SOFT CONTACT LENS FOR DAILY WEAR (July 30, 2004)
  • K012132 — CHROMAGEN V3.0 READING AID SOFT CONTACT LENS (May 9, 2002)

Other clearances for product code NJH

  • K853758 — PY-RITE (December 3, 1985)

FDA data resources