The following data is part of a premarket notification filed by Interojo Inc. with the FDA for I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses For Daily Wear.
| Device ID | K142766 |
| 510k Number | K142766 |
| Device Name: | I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses For Daily Wear |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | INTEROJO INC. #803, Yulchon B/D. 24-1 Youidong Seoul, KR |
| Contact | Si-chul Rho |
| 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 | 2014-09-25 |
| Decision Date | 2015-03-12 |
| Summary: | summary |