510(k) Report

FDA applicant

Lensx Lasers, Inc.

Laguna Beach, CA4 decisions2009–20100 recalls

FDA records 4 decisions for Lensx Lasers, Inc. (Laguna Beach, CA) from 2009 to 2010: 4 510(k) clearances. All are in product code OOE (Ophthalmic Femtosecond Laser). Its devices cite 30 predicates, 5 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 Lensx Lasers, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2010

2009: 22010: 2
2009high 2 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Lensx Lasers, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Lensx Lasers, 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 Laser4decisions

Whose devices does it build on?

Its devices cite 30 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 19 times; 5 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.

  • K101626Lensx Laser SystemLensx Lasers, Inc. · 20107cite it
  • K082947Lensx 550 Laser SystemLensx Lasers, Inc. · 20097cite it
  • K094052Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 20104cite it
  • K092647Lensx 550 Laser SystemLensx Lasers, Inc. · 20091cites it

What has FDA decided for it lately?

  • K101626Lensx Laser SystemLensx Lasers, Inc. · 2010
  • K094052Lensx 550 Laser System. Model 550Lensx Lasers, Inc. · 2010
  • K092647Lensx 550 Laser SystemLensx Lasers, Inc. · 2009
  • K082947Lensx 550 Laser SystemLensx Lasers, Inc. · 2009

All 4 as Lensx Lasers, Inc. →