The following data is part of a premarket notification filed by Vision Science Co Ltd with the FDA for Isens (polymacon) Spherical And Toric Daily Wear Soft Contact Lenses (clear, Tinted, And Cosmetic Tinted).
| Device ID | K132714 |
| 510k Number | K132714 |
| Device Name: | ISENS (POLYMACON) SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES (CLEAR, TINTED, AND COSMETIC TINTED) |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | VISION SCIENCE CO LTD 21225 NW WILKINS ST. Beaverton, OR 97006 |
| Contact | Bret Andre |
| Correspondent | Bret Andre VISION SCIENCE CO LTD 21225 NW WILKINS ST. Beaverton, OR 97006 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-30 |
| Decision Date | 2014-03-05 |
| Summary: | summary |