The following data is part of a premarket notification filed by Abbconcise Optical Group, Llc with the FDA for Concise, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A).
| Device ID | K111267 |
| 510k Number | K111267 |
| Device Name: | CONCISE, SILICONE HYDROGEL DAILY WEAR SOFT CONTACT LENS (EFROFILCON A) |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | ABBCONCISE OPTICAL GROUP, LLC 806 KIMBALL AVENUE Grand Junction, CO 81501 |
| Contact | Martin Dalsingh |
| Correspondent | Martin Dalsingh ABBCONCISE OPTICAL GROUP, LLC 806 KIMBALL AVENUE Grand Junction, CO 81501 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-04 |
| Decision Date | 2011-11-08 |
| Summary: | summary |