The following data is part of a premarket notification filed by Art Optical Contact Lens, Inc. with the FDA for Intelliwave, Soft Daily Wear Contact Lens (acofilcon B) Hioxifilcon B) Clear And Blue Visibility Tint.
Device ID | K073621 |
510k Number | K073621 |
Device Name: | INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | ART OPTICAL CONTACT LENS, INC. 806 KIMBALL AVENUE Grand Junction, CO 81501 |
Contact | Martin Dalsing |
Correspondent | Martin Dalsing ART OPTICAL CONTACT LENS, INC. 806 KIMBALL AVENUE Grand Junction, CO 81501 |
Product Code | LPL |
CFR Regulation Number | 886.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-12-26 |
Decision Date | 2008-07-03 |
Summary: | summary |