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FDA PRODUCT CODE · CLASS II

OWN — Confocal Optical Imaging

Collection of light signals for visualization of cellular microstructures.

DEVICE CLASS
Class II
REGULATION
21 CFR 876.1500
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
SU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
8
510(K)/PMA CLEARANCES
510k: 8
0
RECALL ENTRIES

Recent clearances

K242163SmartsurgN, Inc. · 510k2026-04-20
K254242Karl Storz SE & CO. KG · 510k2026-02-26
K251852VPIX Medical, Inc. · 510k2026-02-13
K253972Karl Storz SE & CO. KG · 510k2026-02-12
K260108Stryker Endoscopy · 510k2026-02-12
K251336Olympus Medical Systems Corp. · 510k2025-11-12
K243711Wuxi Hisky Medical Technologies Co., Ltd. · 510k2025-07-24
K243591Optosurgical, LLC · 510k2025-02-19

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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