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

Exophthalmometer

21 CFR 886.1270 / Ophthalmic
FDA source (opens on fda.gov)

HLS is the FDA product code for Exophthalmometer, a class I device type, regulated under 21 CFR 886.1270. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
HLS
Device name
Exophthalmometer
Regulation
21 CFR 886.1270
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
1
Ingested recalls
0

Clearances, product code HLS

By decision year
1 clearance under product code HLS with a decision year between 1977 and 1977, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code HLS by decision year
YearClearances
19771

Applicants with the most clearances

Product code HLS
Applicants holding the most 510(k) clearances under product code HLS
ApplicantClearances
Welch Allyn Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 33 companies shown, in name order