FDA-Inspected Site

LENSAR, Inc.

4 FDA inspections are on record for LENSAR, Inc. in Orlando, United States.

Clean· No action indicated

Orlando, United States · Last updated August 15, 2026

Overview

  • 4 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-04-16.

At a glance

Inspections

4

Form 483s

2

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
15 Apr 2026 – 16 Apr 2026Medical Devices & Rad HealthClean
19 Sep 2022 – 21 Sep 2022Medical Devices & Rad Health483View 483 →
19 May 2016 – 24 May 2016Medical Devices & Rad HealthClean
18 Mar 2013 – 21 Mar 2013Medical Devices & Rad Health483On file

Observations on record

Form 483 observations cited at this site, most recent first.

21 Sep 2022
21 CFR 1002.10

Failure to submit, distinct marking

Cited by Natasha R Johnson

21 Sep 2022
21 CFR 1002.10

Failure to submit, distinct marking

Cited by Natasha R Johnson

21 Sep 2022
21 CFR 1002.10

Failure to submit, distinct marking

Cited by Natasha R Johnson

21 Sep 2022
21 CFR 1002.10

Failure to submit, distinct marking

Cited by Natasha R Johnson

21 Sep 2022
21 CFR 1002.10

Failure to submit, distinct marking

Cited by Natasha R Johnson

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 1002.10Cited across public-safe Form 483 observations6x

Full site report

Get the verbatim findings behind LENSAR, Inc.'s 2 Form 483s

Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat