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

Biomicroscope, Slit-Lamp, Ac-Powered

21 CFR 886.1850 / Ophthalmic
FDA source (opens on fda.gov)

HJO is the FDA product code for Biomicroscope, Slit-Lamp, Ac-Powered, a class II device type, regulated under 21 CFR 886.1850. As of , FDA records hold 108 510(k) clearances under this code, the most recent dated , and 8 recalls.

Classification record

Product code
HJO
Device name
Biomicroscope, Slit-Lamp, Ac-Powered
Regulation
21 CFR 886.1850
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
109
Ingested recalls
8

Clearances, product code HJO

By decision year
109 clearances under product code HJO with a decision year between 1980 and 2026, 2014 the highest year at 10.
Show the numbers
510(k) clearances under FDA product code HJO by decision year
YearClearances
19802
19812
19821
19831
19841
19868
19871
19882
19902
19912
19922
19936
19943
19958
19962
19972
19983
19991
20001
20012
20031
20051
20065
20071
20084
20093
20105
20112
20132
201410
20152
20165
20179
20182
20201
20221
20241
20262

Applicants with the most clearances

Product code HJO
Applicants holding the most 510(k) clearances under product code HJO
ApplicantClearances
Carl Zeiss Meditec Inc9
Bausch & Lomb Incorporated4
Carl Zeiss, Inc.4
R.H. Burton Co.4
Haag-Streit AG3
Keeler Ltd.3
Kowa Pharmaceuticals America, Inc.3
Reichert, Inc.3
Takagi Seiko Co., Ltd.3
Huvitz Co., Ltd.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 51 companies shown, in name order