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

K223700

BOSS™

510(k) number
K223700
Device name
BOSS™
Applicant
Intelon Optics, Inc. MA · US
Product code
MXK — Device, Analysis, Anterior Segment
Decision date
2024-08-16
Date received
2022-12-12
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Ophthalmic
510(k) Summary (official FDA PDF): K223700.pdf
Official FDA record: K223700
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.