The following data is part of a premarket notification filed by I-see Vision Technology Inc. with the FDA for Ezvue Uv, Soft Daily Wear Contact Lenses (ocufilcon D), Ezvue Colors, Soft Daily Wear Contact Lenses (ocufilcon D).
Device ID | K150293 |
510k Number | K150293 |
Device Name: | EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft Daily Wear Contact Lenses (ocufilcon D) |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | I-SEE VISION TECHNOLOGY INC. 1F, NO. 45, LANE 2, SEC. 2, KUANG-FU ROAD Hsinchu, TW 30071 |
Contact | Isaac Huang |
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 | 2015-02-06 |
Decision Date | 2015-04-15 |
Summary: | summary |