The following data is part of a premarket notification filed by E&e Optics Inc. with the FDA for Elens Rigid Gas Permeable Contact Lens For Daily Wear, Elens Rigid Gas Permeable Contact Lens For Daily Wear Ortho-k.
| Device ID | K181579 |
| 510k Number | K181579 |
| Device Name: | ELens Rigid Gas Permeable Contact Lens For Daily Wear, ELens Rigid Gas Permeable Contact Lens For Daily Wear Ortho-K |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | E&E Optics Inc. 1795 E. Holt Blvd, Unit 104 Ontario, CA 91761 |
| Contact | Bonnie Wan |
| Correspondent | Bret Andre EyeReg Consulting, Inc. 6119 Canter Ln West Linn, OR 97068 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-15 |
| Decision Date | 2018-07-26 |
| Summary: | summary |