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

Instrument, Visual Field, Laser

21 CFR 886.1360 / Ophthalmic
FDA source (opens on fda.gov)

HPJ is the FDA product code for Instrument, Visual Field, Laser, a class II device type, regulated under 21 CFR 886.1360. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HPJ
Device name
Instrument, Visual Field, Laser
Regulation
21 CFR 886.1360
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
5
Ingested recalls
0

Clearances, product code HPJ

By decision year
5 clearances under product code HPJ with a decision year between 1978 and 1986, 1982 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code HPJ by decision year
YearClearances
19781
19822
19851
19861

Applicants with the most clearances

Product code HPJ
Applicants holding the most 510(k) clearances under product code HPJ
ApplicantClearances
Randwal Instrument Co., Inc.2
American Laser Corp.1
Coburn Optical Ind., Inc.1
Coherent Medical Division1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code HPJ.