Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

MRH

Pump, Infusion, Ophthalmic

Product code
MRH
Device name
Pump, Infusion, Ophthalmic
Device class
Class 2
21 CFR
21 CFR 880.5725
Medical specialty
General Hospital
Marketing pathway
510(K)
510(k) clearances (last 3 years)
2
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
20 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-08-04.

NumberDecision dateApplicantDevice nameSummary
K2537602026-08-04Sight Sciences, Inc.OMNI Ultra Surgical System (1-110)PDF
K2435032025-02-14New World Medical, Inc.VIA360™ Surgical SystemFDA

1 summaries are archived here for direct download.

Official FDA classification page: MRH
Classification and pathway per current FDA publications. Data from openFDA (CC0).