The following data is part of a premarket notification filed by Neolens, Inc. with the FDA for Neolens Prescription Spectacle Lens.
| Device ID | K882814 |
| 510k Number | K882814 |
| Device Name: | NEOLENS PRESCRIPTION SPECTACLE LENS |
| Classification | Lens, Spectacle, Non-custom (prescription) |
| Applicant | NEOLENS, INC. 18963 N.E. 4TH CT. Miami, FL 33179 |
| Contact | Clayman, Md |
| Correspondent | Clayman, Md NEOLENS, INC. 18963 N.E. 4TH CT. Miami, FL 33179 |
| Product Code | HQG |
| CFR Regulation Number | 886.5844 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-08 |
| Decision Date | 1988-07-29 |