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HKK — Telescope, Spectacle, Low-Vision Class I

FDA Device Classification

FDA product code HKK covers "Telescope, Spectacle, Low-Vision", a Class I medical device regulated under 21 CFR 886.5870. Submissions are reviewed by the Ophthalmic panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
HKK
Device Class
Class I
Regulation Number
886.5870
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K870203keeler instrumentsKEELER LVA SYSTEM MULTI-CAP SERIES LVA51-1/2/3/4/5February 12, 1987
K864594global eye careDUALENZ LOW VISION EYEWEARJanuary 20, 1987

FDA data resources