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FDA PRODUCT CODE · CLASS II

OZC — Over The Counter Thermal Treatment For Acne.

For the treatment of mild to moderate inflammatory acne.

DEVICE CLASS
Class II
REGULATION
21 CFR 890.5740
MEDICAL SPECIALTY
Physical Medicine
REVIEW PANEL
SU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

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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