The following data is part of a premarket notification filed by Valley Contax, Inc. with the FDA for Custom Stable Rigid Gas Permeable Scleral Contact Lens.
| Device ID | K213880 |
| 510k Number | K213880 |
| Device Name: | Custom Stable Rigid Gas Permeable Scleral Contact Lens |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | Valley Contax, Inc. 200 South Mill St. Springfield, OR 97477 |
| Contact | Josh Adams |
| Correspondent | Bret Andre EyeReg Consulting, Inc. 6119 Canter Lane West Linn, OR 97068 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-13 |
| Decision Date | 2022-01-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860011844112 | K213880 | 000 |
| 00860011844105 | K213880 | 000 |
| 00860011844136 | K213880 | 000 |
| 00860011844129 | K213880 | 000 |