510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162039Substantially Equivalent

OptosAdvance 4.0 Software

Optos PLC., Dunfermline, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162039 is the FDA 510(k) clearance record for OptosAdvance 4.0 Software, a class II device, cleared for Optos Plc. on under FDA product code NFJ (System, Image Management, Ophthalmic). FDA records list 6 510(k) clearances for Optos Plc., from to . As of , FDA records show no recalls naming K162039.

Clearance record

Decision date
Received
(201 days to decision)
Product code
NFJ System, Image Management, Ophthalmic
Regulation
21 CFR 892.2050
Device class
Class II
Review panel
Radiology
Applicant
Optos Plc. Queensferry House, Dunfermline, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NFJ

Trailing 12 months
2 clearances under product code NFJ in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NFJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20261
August 20260
September 20260
October 20260