The following data is part of a premarket notification filed by Soft-sert with the FDA for Soft Lens Inserter.
| Device ID | K780931 |
| 510k Number | K780931 |
| Device Name: | SOFT LENS INSERTER |
| Classification | Inserter/remover Contact Lens |
| Applicant | SOFT-SERT 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KYE |
| CFR Regulation Number | 886.5420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-06 |
| Decision Date | 1978-06-28 |