The following data is part of a premarket notification filed by Gelflex Laboratories with the FDA for Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens.
| Device ID | K181558 |
| 510k Number | K181558 |
| Device Name: | Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | Gelflex Laboratories 52 Mulgul Road Malaga, AU 6090 |
| Contact | David Masel |
| Correspondent | Bret Andre EyeReg Consulting, Inc. 6119 Canter Ln 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 | 2018-06-13 |
| Decision Date | 2018-09-06 |
| Summary: | summary |