The following data is part of a premarket notification filed by Volk Optical Inc. with the FDA for Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens.
| Device ID | K151961 |
| 510k Number | K151961 |
| Device Name: | Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens |
| Classification | Lens, Contact, Polymethylmethacrylate, Diagnostic |
| Applicant | Volk Optical Inc. 7893 Enterprise Drive Mentor, OH 44060 |
| Contact | Meghan M Leonard |
| Correspondent | Meghan M Leonard Volk Optical Inc. 7893 Enterprise Drive Mentor, OH 44060 |
| Product Code | HJK |
| CFR Regulation Number | 886.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-16 |
| Decision Date | 2015-08-18 |
| Summary: | summary |