510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
HLMClass I

Instrument, Measuring, Lens, Ac-Powered

21 CFR 886.1425 / Ophthalmic
FDA source (opens on fda.gov)

HLM is the FDA product code for Instrument, Measuring, Lens, Ac-Powered, a class I device type, regulated under 21 CFR 886.1425. As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
HLM
Device name
Instrument, Measuring, Lens, Ac-Powered
Regulation
21 CFR 886.1425
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
16
Ingested recalls
1

Clearances, product code HLM

By decision year
16 clearances under product code HLM with a decision year between 1978 and 1994, 1993 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code HLM by decision year
YearClearances
19781
19792
19801
19862
19881
19921
19935
19943

Applicants with the most clearances

Product code HLM
Applicants holding the most 510(k) clearances under product code HLM
ApplicantClearances
R.H. Burton Co.3
Marco Ophthalmic, Inc.2
Nidek, Inc.2
Bausch & Lomb Incorporated1
Canon Medical Components U.S.A., Inc.1
Hoya Corp. USA1
Intermedics, Inc.1
Leica, Inc.1
Rodenstock Instrument Corp.1
Smr1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 63 companies shown, in name order