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HLG — Pupillometer, Ac-Powered Class I

FDA Device Classification

FDA product code HLG covers "Pupillometer, Ac-Powered", a Class I medical device regulated under 21 CFR 886.1700. 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
HLG
Device Class
Class I
Regulation Number
886.1700
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K920937trek medical productsCOMPUTERIZED PUPILOctober 2, 1992
K895609pulse medical instrumentsPUPIL PATHWAY ANALYZER (PPA)November 2, 1989
K802351minami, tomine and lewF110 PHOTO BINOCULAR OPHTHALMOSCOPEDecember 17, 1980

FDA data resources