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FDA product code QCB

Phakic Toric Intraocular Lens

OphthalmicClass 321 CFR 886.3600Implantable
Verified
US regulatory classifications
US Product Code (FDA)
QCB
View Product Code Classification
US Risk Class (FDA)
Class 3
US Regulation (CFR)
21 CFR 886.3600
View CFR Regulation
Medical specialty
Ophthalmic
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
No
Third party review
Not Eligible
Definition

Intended to be implanted within the eye to optically correct astigmatism (with or without other refractive errors), without removing the natural crystalline lens.

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About this record

Phakic Toric Intraocular Lens is a medical device type in the Ophthalmic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.