510(k) Report

FDA applicant

Astron Clinica Limited

Crofton, MD3 decisions2002–20070 recalls

FDA records 3 decisions for Astron Clinica Limited (Crofton, MD) from 2002 to 2007: 3 510(k) clearances. All are in product code PSN (Light Based Imaging). Its devices cite 1 predicate, 1 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, general and plastic surgery panel, where it files most

How often FDA has decided Astron Clinica Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • PSNLight Based Imaging3decisions

Who builds on its devices?

Later devices cite its devices 3 times; 1 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.

  • K023729Siascope IIAstron Clinica Limited · 20032cite it
  • K062736Siascope VAstron Clinica Limited · 20071cites it

What has FDA decided for it lately?

  • K062736Siascope VAstron Clinica Limited · 2007
  • K023729Siascope IIAstron Clinica Limited · 2003
  • K011273SI AscopeAstron Clinica Limited · 2002

All 3 as Astron Clinica Limited →

Other applicant names beginning “Astron”

FDA records each applicant name separately; these may or may not be the same firm.

Astron Dental Corp. 6