The following data is part of a premarket notification filed by Specialeyes Llc with the FDA for Specialeyes 50 And Specialeyes 49 Shpere And Toric Soft Contact Lenses.
| Device ID | K060821 |
| 510k Number | K060821 |
| Device Name: | SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT LENSES |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | SPECIALEYES LLC 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Contact | Arthur Ward |
| Correspondent | Arthur Ward SPECIALEYES LLC 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-27 |
| Decision Date | 2006-05-18 |
| Summary: | summary |