Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- Diagnostic DevicesCFR Sub-Part
- General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- MRHPump, Infusion, Ophthalmic2Product Code
- K212797iPrime Viscodelivery System2Cleared 510(K)
- K211680Streamline Surgical System2Cleared 510(K)
- K202678OMNI Surgical System2Cleared 510(K)
- K201953OMNI PLUS Surgical System2Cleared 510(K)
- K173332OMNI Surgical System2Cleared 510(K)
- K171905VISCO 360 Viscosurgical System2Cleared 510(K)
- K143205Viscoelastic Injector2Cleared 510(K)
- K132494VISCOELASTIC INJECTOR2Cleared 510(K)
- K050716ISCIENCE SURGICAL VISCOINJECTOR2Cleared 510(K)
- K000420SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 100032Cleared 510(K)
- Show All 16 Submissions
- MiscellaneousMiscellaneous
- Prosthetic DevicesCFR Sub-Part
- Surgical DevicesCFR Sub-Part
- Therapeutic DevicesCFR Sub-Part
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
OMNI Surgical System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K173332
- 510(k) Type
- Traditional
- Applicant
- Sight Sciences, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/21/2017
- Days to Decision
- 59 days
- Submission Type
- Summary