510(k) Report

FDA applicant

Lensar, Inc.

Orlando, FL14 decisions2010–20220 recalls

FDA records 14 decisions for Lensar, Inc. (Orlando, FL) from 2010 to 2022: 14 510(k) clearances. Most are in product codes OOE (Ophthalmic Femtosecond Laser) and HQC (Unit, Phacofragmentation). Since 2016 its 510(k)s took a median of 88 days from receipt to decision, against 99 for FDA’s reviews in the same codes and years. Its devices cite 31 predicates, 19 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Lensar, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2010: 12011: 22012: 22013: 12015: 22017: 22018: 32022: 1
2010high 3 (2018) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Lensar, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Lensar, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • OOEOphthalmic Femtosecond Laser13decisions
  • HQCUnit, Phacofragmentation1decision

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 88 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 99 days; 3 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 31 predicates; 19 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 21 times; 19 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K090633Lensar Laser SystemLensar, Inc. · 20104cite it
  • K102727Lensar Laser System for Anterior CapsulotomyLensar, Inc. · 20113cite it
  • K112098TBDLensar, Inc. · 20112cite it
  • K120214TBDLensar, Inc. · 20122cite it
  • K143010LENSAR Laser System - fs 3DLensar, Inc. · 20152cite it
  • K123859TBDLensar, Inc. · 20132cite it

What has FDA decided for it lately?

  • K220259ALLY Adaptive Cataract Treatment SystemLensar, Inc. · 2022
  • K182795LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2018
  • K181430LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2018
  • K173346LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2018
  • K171337LENSAR Laser System – fs 3D (LLS-fs 3D)Lensar, Inc. · 2017
  • K170576LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2017
  • K152453LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc. · 2015
  • K143010LENSAR Laser System - fs 3DLensar, Inc. · 2015

All 14 as Lensar, Inc. →