HLP — Target, Fusion And Stereoscopic Class I

FDA Device Classification

FDA product code HLP covers "Target, Fusion And Stereoscopic", a Class I medical device regulated under 21 CFR 886.1880. Submissions are reviewed by the Ophthalmic panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
HLP
Device Class
Class I
Regulation Number
886.1880
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K883471technitexVKG 1000, VIDEO KERATOMETERNovember 8, 1988
K874251richmond productsWORTH 4 DOT TEST DISTANCE C/W MUSCLE LIGHTJanuary 11, 1988
K874250richmond productsTHREE CHAR. TEST-CHILD & WORTH 4 DOT TEST NEARPT.January 11, 1988