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

HNY

Cystotome

Product code
HNY
Device name
Cystotome
Device class
Class 1
21 CFR
21 CFR 886.4350
Medical specialty
Ophthalmic
Marketing pathway
510(K) Exempt
510(k) clearances (all years, FDA)
20 (all years; only the last 3 years are listed here)
Official FDA classification page: HNY
Classification and pathway per current FDA publications. Data from openFDA (CC0).