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

Case, Contact Lens

21 CFR 886.5928 / Ophthalmic
FDA source (opens on fda.gov)

LRX is the FDA product code for Case, Contact Lens, a class II device type, regulated under 21 CFR 886.5928. As of , FDA records hold 82 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LRX
Device name
Case, Contact Lens
Regulation
21 CFR 886.5928
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
82
Ingested recalls
0

Clearances, product code LRX

By decision year
82 clearances under product code LRX with a decision year between 1984 and 2026, 1988 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code LRX by decision year
YearClearances
19842
19861
19873
19888
19893
19908
19922
19932
19942
19957
19961
19971
19982
19992
20001
20011
20021
20032
20042
20053
20071
20091
20101
20112
20123
20134
20143
20152
20162
20175
20231
20241
20251
20261

Applicants with the most clearances

Product code LRX
Applicants holding the most 510(k) clearances under product code LRX
ApplicantClearances
Alcon Laboratories6
Applied Laboratories, Inc.6
FGX International Inc.6
Bausch & Lomb Incorporated3
Kestrel3
Paragon Vision Sciences, Inc.3
Ryder Intl. Corp.3
Bradstreet Clinical Research Assoc., Inc.2
Hyman, Phelps & McNamara, P.C.2
Optimum Manufacturers, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 42 companies shown, in name order