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

Prosthesis, Eyelid Spacer/Graft, Polymer

21 CFR 886.3130 / Ophthalmic
FDA source (opens on fda.gov)

QWU is the FDA product code for Prosthesis, Eyelid Spacer/Graft, Polymer, a class II device type, regulated under 21 CFR 886.3130. FDA's definition for this code reads: "For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid and eyelid area". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 3 recalls.

Classification record

Product code
QWU
Device name
Prosthesis, Eyelid Spacer/Graft, Polymer
FDA definition
For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid and eyelid area.
Regulation
21 CFR 886.3130
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
3

Clearances, product code QWU

By decision year
1 clearance under product code QWU with a decision year between 2023 and 2023, 2023 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QWU by decision year
YearClearances
20231

Applicants with the most clearances

Product code QWU
Applicants holding the most 510(k) clearances under product code QWU
ApplicantClearances
Corneat Vision, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code