510(k) Report

FDA applicant

W.C. Heraeus GmbH

West Germany, DE2 decisions1988–19894 recalls

FDA records 2 decisions for W.C. Heraeus GmbH (West Germany, DE) from 1988 to 1989: 2 510(k) clearances. Most are in product codes FTD (Lamp, Surgical) and HHR (Laser, Surgical, Gynecologic). 4 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, general and plastic surgery panel, where it files most

How often FDA has decided W.C. Heraeus GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for W.C. Heraeus GmbH since 2007.

Recalls per year

4in 2009

2009: 4
2007high 4 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — W.C. Heraeus GmbH 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?

  • FTDLamp, Surgical1decision
  • HHRLaser, Surgical, Gynecologic1decision

What has FDA decided for it lately?

  • K895715Hanaulux (R) 2000W.C. Heraeus GmbH · 19894 recalls
  • K875078Heracure LS 500W.C. Heraeus GmbH · 1988

All 2 as W.C. Heraeus GmbH →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K895715HANAULUX 2005 IXL cupola, P/N: 56076869. Intended to provide visible illumination for…Oct 7, 2009
  • K895715HANAULUX 2004-2005 TV Spring Arm, P/N: 569002998. Intended to provide visible…Oct 7, 2009
  • K895715HANAULUX 2004 IXL cupola, P/N: 56076868 Intended to provide visible illumination for the…Oct 7, 2009
  • K895715HANAULUX 2005 I cupola, P/N: 56076865. Intended to provide visible illumination for the…Oct 7, 2009