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

Aid, Vision Image Intensification

21 CFR 886.5910 / Ophthalmic
FDA source (opens on fda.gov)

HOT is the FDA product code for Aid, Vision Image Intensification, a class I device type, regulated under 21 CFR 886.5910. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HOT
Device name
Aid, Vision Image Intensification
Regulation
21 CFR 886.5910
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
2
Ingested recalls
0

Clearances, product code HOT

By decision year
2 clearances under product code HOT with a decision year between 1986 and 1988, 1986 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HOT by decision year
YearClearances
19861
19881

Applicants with the most clearances

Product code HOT
Applicants holding the most 510(k) clearances under product code HOT
ApplicantClearances
Sensory Aids Corp.1
Swank Plus, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code