The following data is part of a premarket notification filed by Art Optical Contact Lens, Inc. with the FDA for Intelliwave4 With Hpt, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A).
Device ID | K152046 |
510k Number | K152046 |
Device Name: | Intelliwave4 With HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A) |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | ART OPTICAL CONTACT LENS, INC. 3175 3175 3 MILE ROAD Walker, MI 49534 |
Contact | Michael Johnson |
Correspondent | Bret Andre EYEREG CONSULTING, INC. 474 NE 61ST PL Hillsboro, OR 97124 |
Product Code | LPL |
CFR Regulation Number | 886.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-07-23 |
Decision Date | 2015-11-24 |
Summary: | summary |