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

Table, Instrument, Powered, Ophthalmic

21 CFR 886.4855 / Ophthalmic
FDA source (opens on fda.gov)

HRJ is the FDA product code for Table, Instrument, Powered, Ophthalmic, a class I device type, regulated under 21 CFR 886.4855. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HRJ
Device name
Table, Instrument, Powered, Ophthalmic
Regulation
21 CFR 886.4855
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
7
Ingested recalls
0

Clearances, product code HRJ

By decision year
7 clearances under product code HRJ with a decision year between 1984 and 1993, 1984 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HRJ by decision year
YearClearances
19842
19852
19911
19921
19931

Applicants with the most clearances

Product code HRJ
Applicants holding the most 510(k) clearances under product code HRJ
ApplicantClearances
Alcon Laboratories1
Dentsply Intl.1
Marco Ophthalmic, Inc.1
Optical Micro Systems, Inc.1
R.H. Burton Co.1
Techna Vision1
Woodlyn, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 52 companies shown, in name order