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 |