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

Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered

21 CFR 886.4100 / Ophthalmic
FDA source (opens on fda.gov)

PUL is the FDA product code for Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered, a class II device type, regulated under 21 CFR 886.4100. FDA's definition for this code reads: "Used to perform anterior capsulotomy during cataract surgery". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PUL
Device name
Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered
FDA definition
Used to perform anterior capsulotomy during cataract surgery
Regulation
21 CFR 886.4100
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
4
Ingested recalls
0

Clearances, product code PUL

By decision year
4 clearances under product code PUL with a decision year between 2017 and 2023, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PUL by decision year
YearClearances
20171
20211
20221
20231

Applicants with the most clearances

Product code PUL
Applicants holding the most 510(k) clearances under product code PUL
ApplicantClearances
Centricity Vision, Inc.3
Mynosys Cellular Devices, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code