The following data is part of a premarket notification filed by Polydev Ltd. with the FDA for Polydev Soft Contact Lenses.
| Device ID | K160977 |
| 510k Number | K160977 |
| Device Name: | PolyDev Soft Contact Lenses |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | Polydev Ltd. Tinure Rd Collon, IE |
| Contact | John Mulvihill |
| Correspondent | Ray Kelly LICENSALE INC 57 LAZY BROOK RD Monroe, CT 06468 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-07 |
| Decision Date | 2016-07-13 |