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

Strabismus Detection Device

21 CFR 886.1342 / Ophthalmic
FDA source (opens on fda.gov)

PMW is the FDA product code for Strabismus Detection Device, a class II device type, regulated under 21 CFR 886.1342. FDA's definition for this code reads: "For the automated detection of misalignment of the visual axes for prescription use only". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
PMW
Device name
Strabismus Detection Device
FDA definition
For the automated detection of misalignment of the visual axes for prescription use only.
Regulation
21 CFR 886.1342
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
No
Ingested clearances
1
Ingested recalls
1

Clearances, product code PMW

By decision year
1 clearance under product code PMW with a decision year between 2016 and 2016, 2016 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PMW by decision year
YearClearances
20161

Applicants with the most clearances

Product code PMW
Applicants holding the most 510(k) clearances under product code PMW
ApplicantClearances
Rebiscan, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code