FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OMNI Surgical System
K Number: K202678
·
Decision Mar 1, 2021
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
18
Applicant Total
11
Review Days
167
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Basic Information
- Device Name
- OMNI Surgical System
- K Number
- K202678
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sight Sciences, Inc.
- Date Received
- September 15, 2020
- Decision Date
- March 1, 2021
- Product Code
- MRH
- Advisory Committee
- General Hospital
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MRH | Pump, Infusion, Ophthalmic | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MRH), ordered by most recent decision date.
VIA360 Surgical System
FDA 510(k)
FDA Class 2
·General Hospital
OMNI Surgical System
FDA 510(k)
FDA Class 2
·General Hospital
TrabEx Pro
FDA 510(k)
FDA Class 2
·General Hospital
iPrime Viscodelivery System
FDA 510(k)
FDA Class 2
·General Hospital
Streamline Surgical System
FDA 510(k)
FDA Class 2
·General Hospital
OMNI PLUS Surgical System
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Sight Sciences, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252409 | TearCare MGX System | Apr 27, 2026 | Substantially Equivalent |
| K242786 | TearCare MGX System | Apr 15, 2025 | Substantially Equivalent |
| K231084 | TearCare MGX System | Dec 27, 2023 | Substantially Equivalent |
| K232214 | OMNI Surgical System | Aug 25, 2023 | Substantially Equivalent |
| K213045 | TearCare System | Dec 21, 2021 | Substantially Equivalent |
| K201953 | OMNI PLUS Surgical System | Aug 11, 2020 | Substantially Equivalent |
| K173332 | OMNI Surgical System | Dec 21, 2017 | Substantially Equivalent |
| K171905 | VISCO 360 Viscosurgical System | Jul 27, 2017 | Substantially Equivalent |
| K143205 | Viscoelastic Injector | Dec 5, 2014 | Substantially Equivalent |
| K132494 | VISCOELASTIC INJECTOR | Oct 22, 2013 | Substantially Equivalent |