The following data is part of a premarket notification filed by X-cel Contacts with the FDA for Flexlens Multifocal Soft Contact Lens, (hioxifilcon A) And (hioxifilcon B) For Daily Wear.
| Device ID | K070308 |
| 510k Number | K070308 |
| Device Name: | FLEXLENS MULTIFOCAL SOFT CONTACT LENS, (HIOXIFILCON A) AND (HIOXIFILCON B) FOR DAILY WEAR |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | X-CEL CONTACTS 581 WHILES COURT Erie, CO 80516 -4933 |
| Contact | Kevin Randall |
| Correspondent | Kevin Randall X-CEL CONTACTS 581 WHILES COURT Erie, CO 80516 -4933 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-01 |
| Decision Date | 2007-03-12 |
| Summary: | summary |