The following data is part of a premarket notification filed by C&e Gp Specialist, Inc. with the FDA for Isee (roflufocon D, Roflufocon E) Daily Wear Orthokeratology Contact Lenses.
| Device ID | K183200 |
| 510k Number | K183200 |
| Device Name: | ISee (roflufocon D, Roflufocon E) Daily Wear Orthokeratology Contact Lenses |
| Classification | Lens, Contact (orthokeratology) |
| Applicant | C&E GP Specialist, Inc. 15970 Bernardo Center Drive, San Diego, CA 92127 |
| Contact | Steve Wagner |
| Correspondent | Bret Andre EyeReg Consulting, Inc. 6119 Canter Lane West Linn, OR 97068 |
| Product Code | MUW |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-19 |
| Decision Date | 2019-01-09 |
| Summary: | summary |