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FDA PRODUCT CODE · CLASS III

LPO — Gases Used Within Eye To Place Pressure On Detached Retina

DEVICE CLASS
Class III
REGULATION
21 CFR 886.4270
MEDICAL SPECIALTY
Ophthalmic
REVIEW PANEL
OP
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
pma: 3
0
RECALL ENTRIES

Recent clearances

P220030Alcon Research, LLC · pma2026-05-28
P230012Alcon Research, LLC · pma2026-05-28
P900066Airgas Therapeutics, LLC · pma2026-04-30

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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