510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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HMFClass I

Stand, Instrument, Ac-Powered, Ophthalmic

21 CFR 886.1860 / Ophthalmic
FDA source (opens on fda.gov)

HMF is the FDA product code for Stand, Instrument, Ac-Powered, Ophthalmic, a class I device type, regulated under 21 CFR 886.1860. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HMF
Device name
Stand, Instrument, Ac-Powered, Ophthalmic
Regulation
21 CFR 886.1860
Device class
Class I
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
15
Ingested recalls
0

Clearances, product code HMF

By decision year
15 clearances under product code HMF with a decision year between 1979 and 1994, 1993 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code HMF by decision year
YearClearances
19792
19812
19831
19842
19851
19911
19934
19942

Applicants with the most clearances

Product code HMF
Applicants holding the most 510(k) clearances under product code HMF
ApplicantClearances
Bausch & Lomb Incorporated2
Luneau Laboratories2
R.H. Burton Co.2
Rota Systems Medfurniture, Inc.2
CooperVision, Inc.1
Dentsply Intl.1
F. & F. Koenigkramer1
Luneau Ophtalmologie SA1
Marco Ophthalmic, Inc.1
Rota Systems,Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 40 companies shown, in name order