The following data is part of a premarket notification filed by Dk Medivision Co., Ltd. with the FDA for Trevues (polymacon) Soft (hydrophilic) Contact Lenses (tinted, Color).
| Device ID | K220045 |
| 510k Number | K220045 |
| Device Name: | TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | DK Medivision Co., Ltd. 23 Busong 1-gil, Jiksan-eup Chungcheongnam-do, KR 31038 |
| Contact | Henry Hong |
| Correspondent | Bret Andre EyeReg Consulting Inc. 6119 Canter Lane West Linn, OR 97068 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-05 |
| Decision Date | 2022-08-05 |