OMNI Surgical System
FDA 510(k) K232214 · Sight Sciences, Inc.
510(k) numberK232214
Submission
- Device name
- OMNI Surgical System
- Applicant
- Sight Sciences, Inc.
Menlo Park, CA, US - Received
- July 26, 2023
- Decision date
- August 25, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRH – Pump, Infusion, Ophthalmic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
Other 510(k)s with product code MRH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253760 | OMNI Ultra Surgical System (1-110)MRH · Traditional | Sight Sciences, Inc. | 08/04/2026SE |
| K243503 | VIA360 Surgical SystemMRH · Traditional | New World Medical, Inc. | 02/14/2025SE |
| K213173 | TrabEx ProMRH · Traditional | Microsurgical Technologies, Inc. | 06/08/2022SE |
| K212797 | iPrime Viscodelivery SystemMRH · Traditional | Glaukos | 01/06/2022SE |
| K211680 | Streamline Surgical SystemMRH · Traditional | New World Medical, Inc. | 10/08/2021SE |
| K202678 | OMNI Surgical SystemMRH · Traditional | Sight Sciences, Inc. | 03/01/2021SE |
| K201953 | OMNI PLUS Surgical SystemMRH · Special | Sight Sciences, Inc. | 08/11/2020SE |
| K173332 | OMNI Surgical SystemMRH · Traditional | Sight Sciences, Inc. | 12/21/2017SE |
| K171905 | VISCO 360 Viscosurgical SystemMRH · Special | Sight Sciences, Inc. | 07/27/2017SE |
| K143205 | Viscoelastic InjectorMRH · Special | Sight Sciences, Inc. | 12/05/2014SE |
More from Sight Sciences, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K262479 | TearCare SystemORZ · Special | 08/18/2026SE |
| K253760 | OMNI Ultra Surgical System (1-110)MRH · Traditional | 08/04/2026SE |
| K252409 | TearCare MGX SystemORZ · Traditional | 04/27/2026SE |
| K242786 | TearCare MGX SystemORZ · Traditional | 04/15/2025SE |
| K231084 | TearCare MGX SystemORZ · Traditional | 12/27/2023SE |
| K213045 | TearCare SystemORZ · Traditional | 12/21/2021SE |
| K202678 | OMNI Surgical SystemMRH · Traditional | 03/01/2021SE |
| K201953 | OMNI PLUS Surgical SystemMRH · Special | 08/11/2020SE |
| K173332 | OMNI Surgical SystemMRH · Traditional | 12/21/2017SE |
| K171905 | VISCO 360 Viscosurgical SystemMRH · Special | 07/27/2017SE |
Questions and answers
When was OMNI Surgical System cleared by the FDA?
OMNI Surgical System (K232214) received a 510(k) decision of Substantially Equivalent on August 25, 2023, 30 days after the submission was received.
What is the product code of K232214?
The FDA product code is MRH – Pump, Infusion, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 880.5725.