The following data is part of a premarket notification filed by Phakos with the FDA for Endocular Viewing Lenses And Silicone Ring.
| Device ID | K173944 |
| 510k Number | K173944 |
| Device Name: | Endocular Viewing Lenses And Silicone Ring |
| Classification | Lens, Contact, Polymethylmethacrylate, Diagnostic |
| Applicant | Phakos 62 Rue Kleber Montreuil, FR 93100 |
| Contact | J. D. Webb |
| Correspondent | J. D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 |
| Product Code | HJK |
| CFR Regulation Number | 886.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-26 |
| Decision Date | 2018-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B564MVLV562 | K173944 | 000 |
| B564MVLV45HR2 | K173944 | 000 |
| B564MVLV452 | K173944 | 000 |
| B564MVLV43HR2 | K173944 | 000 |
| B564MVLV432 | K173944 | 000 |
| B564MVLV42HR2 | K173944 | 000 |
| B564MVLV422 | K173944 | 000 |
| B564MVLV41HR2 | K173944 | 000 |
| B564MVLV412 | K173944 | 000 |
| B564MVLV40HR2 | K173944 | 000 |
| B564MVLV462 | K173944 | 000 |
| B564MVLV472 | K173944 | 000 |
| B564MVLV552 | K173944 | 000 |
| B564MVLV542 | K173944 | 000 |
| B564MVLV532 | K173944 | 000 |
| B564MVLV522 | K173944 | 000 |
| B564MVLV512 | K173944 | 000 |
| B564MVLV502 | K173944 | 000 |
| B564MVLV492 | K173944 | 000 |
| B564MVLV48HR2 | K173944 | 000 |
| B564MVLV482 | K173944 | 000 |
| B564MVAS102 | K173944 | 000 |