The following data is part of a premarket notification filed by Vizionfocus, Inc. with the FDA for Legacy (ocufilcon D) Performance- Tinted Soft (hydrophilic) Daily Wear Contact Lenses.
| Device ID | K192225 |
| 510k Number | K192225 |
| Device Name: | Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | VizionFocus, Inc. No.66, Youyi Rd. Zhunan Township, TW 350 |
| Contact | Angus Shih |
| 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 | 2019-08-16 |
| Decision Date | 2019-12-09 |