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FDA PRODUCT CODE · CLASS II

OBO — Tomography, Optical Coherence

Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.

DEVICE CLASS
Class II
REGULATION
21 CFR 886.1570
MEDICAL SPECIALTY
Ophthalmic
REVIEW PANEL
OP
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
6
510(K)/PMA CLEARANCES
510k: 6
0
RECALL ENTRIES

Recent clearances

K253837Heidelberg Engineering GmbH · 510k2026-05-07
K252633Cylite Pty. , Ltd. · 510k2025-12-23
K250553Tomey Corporation · 510k2025-07-18
K250868Heidelberg Engineering GmbH · 510k2025-05-12
K240924Heidelberg Engineering GmbH · 510k2024-12-13
K241163Heidelberg Engineering GmbH · 510k2024-10-11

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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