510(k) Report

FDA applicant

Ophthalmed, LLC

Alpharetta, GA3 decisions2002–20150 recalls

FDA records 3 decisions for Ophthalmed, LLC (Alpharetta, GA) from 2002 to 2015: 3 510(k) clearances. Most are in product codes HQF (Laser, Ophthalmic) and GEX (Powered Laser Surgical Instrument). Its devices cite 8 predicates, 3 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 Ophthalmed, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ophthalmed, LLC’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?

  • HQFLaser, Ophthalmic2decisions
  • GEXPowered Laser Surgical Instrument1decision

Whose devices does it build on?

Its devices cite 8 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 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.

  • K02169620G Sma Laser Fiber, Model LF20; 25G Sma Laser Fiber, Model LF25Ophthalmed, LLC · 20024cite it
  • K05080720G Sma Laser Fiber, Model LF100Ophthalmed, LLC · 20052cite it
  • K142830Ophthalmed Bending Laser ProbesOphthalmed, LLC · 20151cites it

What has FDA decided for it lately?

  • K142830Ophthalmed Bending Laser ProbesOphthalmed, LLC · 2015
  • K05080720G Sma Laser Fiber, Model LF100Ophthalmed, LLC · 2005
  • K02169620G Sma Laser Fiber, Model LF20; 25G Sma Laser Fiber, Model LF25Ophthalmed, LLC · 2002

All 3 as Ophthalmed, LLC →