510(k) Report

FDA applicant

Optimedica Corporation

Sunnyvale, CA8 decisions2006–20166 recalls

FDA records 8 decisions for Optimedica Corporation (Sunnyvale, CA) from 2006 to 2016: 8 510(k) clearances. Most are in product codes OOE (Ophthalmic Femtosecond Laser) and GEX (Powered Laser Surgical Instrument). Its devices cite 12 predicates, 3 of them its own earlier devices. 6 recalls are 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 Optimedica Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2008: 12009: 12010: 12011: 12012: 12014: 12016: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2021

2012: 12013: 12015: 22018: 12021: 1
2007high 2 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Optimedica Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Optimedica Corporation’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
  • GEXPowered Laser Surgical Instrument3decisions
  • HQFLaser, Ophthalmic1decision

Whose devices does it build on?

Its devices cite 12 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 16 times; 3 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.

  • K081744Pascal Synthesis Delivery SystemOptimedica Corporation · 20084cite it
  • K091666Pascal Photocoagulator, Pascal-USOptimedica Corporation · 20093cite it
  • K100019Pascal Streamline PhotocoagulatorOptimedica Corporation · 20103cite it
  • K121091Catalys Precision Laser SystemOptimedica Corporation · 20122cite it
  • K062336Optimedica Laser Indirect OphthalmoscopeOptimedica Corporation · 20061cites it
  • K161455Catalys Precision Laser SystemOptimedica Corporation · 20161cites it

What has FDA decided for it lately?

  • K161455Catalys Precision Laser SystemOptimedica Corporation · 2016
  • K141079Optimedica Catalys Precision Laser SystemOptimedica Corporation · 20143 recalls
  • K121091Catalys Precision Laser SystemOptimedica Corporation · 20122 recalls
  • K113479Optimedica Catalys Precision Laser SystemOptimedica Corporation · 20112 recalls
  • K100019Pascal Streamline PhotocoagulatorOptimedica Corporation · 20101 recall
  • K091666Pascal Photocoagulator, Pascal-USOptimedica Corporation · 2009
  • K081744Pascal Synthesis Delivery SystemOptimedica Corporation · 2008
  • K062336Optimedica Laser Indirect OphthalmoscopeOptimedica Corporation · 2006

All 8 as Optimedica Corporation →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K113479Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I…Oct 21, 2021Class II
  • K113479OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33…May 9, 2018Class II
  • K141079OptiMedica Catalys Precision Laser System; Model No (s). Catalys-U (US), and Catalys-I…Feb 20, 2015Class II
  • K141079Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International…Feb 20, 2015Class II
  • K121091Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser…Dec 20, 2013Class II
  • K100019PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.Mar 27, 2012Class II