Company · US
Vioptix, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2025. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 26, 2025 | K250519 | Lap.Ox Laparoscopic Tissue Oximeter ViOptix, Inc. | MUD |
| Feb 28, 2024 | K233488 | Intra.Ox 2.0 Handheld Tissue Oximeter Vioptix, Inc. | MUD |
| May 3, 2022 | K221010 | Intra.Ox 2.0 Handheld Tissue Oximeter Vioptix, Inc. | MUD |
| Sep 16, 2019 | K191676 | Intra.Ox 2.0 Handheld Tissue Oximeter Vioptix, Inc. | MUD |
| Nov 16, 2017 | K163472 | Intra.Ox Handheld Tissue Oximeter Vioptix, Inc. | MUD |
| Sep 12, 2014 | K133983 | INTRA. OX HANDHELD TISSUE OXIMETER Vioptix, Inc. | MUD |
| Jul 1, 2014 | K141234 | ODISSEY TISSUE OXIMETER Vioptix, Inc. | MUD |
| Apr 17, 2009 | K090679 | VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM Vioptix, Inc. | MVR |
| Jan 10, 2005 | K042657 | VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2 Vioptix, Inc. | MUD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||