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

Spectacle, Operating (Loupe), Ophthalmic

21 CFR 886.4770 / Ophthalmic
FDA source (opens on fda.gov)

HOH is the FDA product code for Spectacle, Operating (Loupe), Ophthalmic, a class I device type, regulated under 21 CFR 886.4770. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HOH
Device name
Spectacle, Operating (Loupe), Ophthalmic
Regulation
21 CFR 886.4770
Device class
Class I
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code HOH

By decision year
3 clearances under product code HOH with a decision year between 1981 and 1994, 1981 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HOH by decision year
YearClearances
19811
19881
19941

Applicants with the most clearances

Product code HOH
Applicants holding the most 510(k) clearances under product code HOH
ApplicantClearances
Exeter Instruments, Inc.1
General Scientific Corp.1
Seiler Instrument & Mfg. Co.,Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order