The following data is part of a premarket notification filed by Art Optical Contact Lens Inc with the FDA for Ampleye Scleral Rgp Lens (roflufocon D, Roflufocon E, Hexafocon A, Paflufocon D).
| Device ID | K172314 |
| 510k Number | K172314 |
| Device Name: | Ampleye Scleral RGP Lens (roflufocon D, Roflufocon E, Hexafocon A, Paflufocon D) |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | Art Optical Contact Lens Inc 3175 3 Mile Rd NW Grand Rapids, MI 49534 |
| Contact | Mike Johnson |
| 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 | 2017-08-01 |
| Decision Date | 2017-09-20 |
| Summary: | summary |