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

Light, Headband, Surgical

21 CFR 886.4335 / Ophthalmic
FDA source (opens on fda.gov)

FSR is the FDA product code for Light, Headband, Surgical, a class II device type, regulated under 21 CFR 886.4335. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FSR
Device name
Light, Headband, Surgical
Regulation
21 CFR 886.4335
Device class
Class II
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
4
Ingested recalls
0

Clearances, product code FSR

By decision year
4 clearances under product code FSR with a decision year between 2000 and 2011, 2003 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FSR by decision year
YearClearances
20001
20032
20111

Applicants with the most clearances

Product code FSR
Applicants holding the most 510(k) clearances under product code FSR
ApplicantClearances
Welch Allyn Inc2
Angiolaz, Inc.1
Integra LifeSciences Corporation1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order