The following data is part of a premarket notification filed by Advanced Vision Technologies with the FDA for Eyeprintpro (roflufocon D) Scleral Gp Lenses.
| Device ID | K152724 |
| 510k Number | K152724 |
| Device Name: | EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | ADVANCED VISION TECHNOLOGIES 969 SOUTH KIPLING PARKWAY Lakewood, CO 80226 |
| Contact | Keith Parker |
| Correspondent | Bret Andre EYEREG CONSULTING, INC. 474 NE 61ST PL Hillsboro, OR 97124 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-22 |
| Decision Date | 2016-04-27 |
| Summary: | summary |