The following data is part of a premarket notification filed by Innova Vision Inc. with the FDA for Discon Plus (etafilcon A) Contact Lens Visibility Tint With Uv Blocker.
Device ID | K083288 |
510k Number | K083288 |
Device Name: | DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | INNOVA VISION INC. 2904 N. BOLDT DRIVE Flagstaff, AZ 86001 |
Contact | Jennifer Reich |
Correspondent | Jennifer Reich INNOVA VISION INC. 2904 N. BOLDT DRIVE Flagstaff, AZ 86001 |
Product Code | LPL |
CFR Regulation Number | 886.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-11-07 |
Decision Date | 2009-09-03 |
Summary: | summary |