The following data is part of a premarket notification filed by Unilens Corp., Usa with the FDA for Axion Plus (methafilcon A) Soft (hydrophilic) Aspheric Contract Lens.
| Device ID | K002408 |
| 510k Number | K002408 |
| Device Name: | AXION PLUS (METHAFILCON A) SOFT (HYDROPHILIC) ASPHERIC CONTRACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | UNILENS CORP., USA 10431 72ND ST. NORTH Largo, FL 33777 |
| Contact | Charlotte B Couecou |
| Correspondent | Charlotte B Couecou UNILENS CORP., USA 10431 72ND ST. NORTH Largo, FL 33777 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-07 |
| Decision Date | 2000-10-17 |