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HLM — Instrument, Measuring, Lens, Ac-Powered Class I

FDA Device Classification

FDA product code HLM covers "Instrument, Measuring, Lens, Ac-Powered", a Class I medical device regulated under 21 CFR 886.1425. Submissions are reviewed by the Ophthalmic panel. At least 16 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
HLM
Device Class
Class I
Regulation Number
886.1425
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K944022leicaLENSCHEKNovember 17, 1994
K940997hoya corp. usaAL-3300September 29, 1994
K936199canon usaAUTOMATIC LENSOMETERSeptember 28, 1994
K930441marco ophthalmicMARCO STANDARD LENSMETERS 101,201July 6, 1993
K930445marco ophthalmicMARCO LM-770 DIGITAL PROJECTION LENSMETERJune 21, 1993
K924776r.h. burtonBURTON LENSMETER - MODEL 2021April 5, 1993
K924788r.h. burtonBURTON LENSMETERApril 5, 1993
K924785r.h. burtonBURTON RADIUSGAUGE - MODEL 2030April 5, 1993
K920861woodlynWOODLYN CLASSIC LENSMETERJuly 30, 1992
K884188nidekNIDEK LM-870 AUTOMATIC LENSMETERNovember 23, 1988
K862518bausch and lombBAUSCH & LOMB VERTOMETER V-5August 11, 1986
K861064nidekLM-850 AUTOMATIC LENSMETERApril 15, 1986
K801767smrDIMENSION I REFRACTION SYSTEMSeptember 16, 1980
K791521intermedicsVERI-VU LENSOMETEROctober 30, 1979
K782096zeiss humphrey systemINSTRUMENTS, OVERREFRACTION SYSTEMJanuary 26, 1979
K781440rodenstock instrumentLENSOMETER MODEL 11September 7, 1978

FDA data resources