Identity
- Trade Name
- OMNI Edge Surgical System FDA UDI
- Generic Name
- Ophthalmic needle, single-use FDA UDI
- Device Name
- OMNI Edge Surgical System FDA UDI
- Model / Reference
- 1-112 FDA UDI
- Description
- OMNI Edge Surgical System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858027006594 FDA UDI
- 510(k) Number
- K232214 FDA UDI
- FDA Product Code
- MRH FDA UDIHMZ FDA UDI
- GMDN Term
- Ophthalmic needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 FDA UDI886.4350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ophthalmic needle, single-useTrabeculotome, single-use
OMNI Edge Surgical System by Sight Sciences, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Trabeculotome, single-use.
- OMNI Surgical System — Sight Sciences, Inc. · Class II
- OMNI(R) Surgical System (US) — Sight Sciences, Inc. · Class I
- Sion Surgical Instrument — Sight Sciences, Inc. · Class I
- OMNI Surgical System — Sight Sciences, Inc. · Class II
Cleared under the same submission
K232214 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sight Sciences, Inc.
Sources (1)
- FDA UDI a9e83f1d-56be-4aed-95d4-8e00738674ea 34 fields · synced Jun 9, 2026