FDA product code SDE

Light Based Device For Dry Age-Related Macular Degeneration

Ophthalmic·Class 2·21 CFR 886.5520
US regulatory classifications
US Product Code (FDA)
SDE
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 886.5520
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Medical specialty
Ophthalmic
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

A light based device for dry age-related macular degeneration is a prescription device intended for use in the application of non- coherent light energy to the eye. The device treats or improves visual acuity in patients with dry age-related macular degeneration.

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About this record

Light Based Device For Dry Age-Related Macular Degeneration 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.

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.