510(k) Report

FDA applicant

Luxtec Corp.

Sturbridge, MA15 decisions1986–199710 recalls

FDA records 15 decisions for Luxtec Corp. (Sturbridge, MA) from 1986 to 1997: 15 510(k) clearances. Most are in product codes EQH (Source, Carrier, Fiberoptic Light) and FSP (Loupe, Diagnostic/Surgical). 10 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 Luxtec Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Luxtec Corp. since 2007.

Recalls per year

8in 2011

2007: 22011: 8
2007high 8 (2011) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Luxtec Corp. 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?

  • EQHSource, Carrier, Fiberoptic Light3decisions
  • FSPLoupe, Diagnostic/Surgical2decisions
  • FCWLight Source, Fiberoptic, Routine2decisions
  • HRXArthroscope2decisions
  • FFSImage, Illumination, Fiberoptic, For Endoscope1decision
  • FWCCamera, Television, Surgical, With Audio1decision

Also: HDG (1), FST (1), HQF (1), GAD (1).

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K890716Luxtec Aco Series 4000 Light SourceLuxtec Corp. · 19891cites it

What has FDA decided for it lately?

  • K973193LuxscopeLuxtec Corp. · 1997
  • K970642TenoscopeLuxtec Corp. · 1997
  • K970562TenosnareLuxtec Corp. · 1997
  • K950960Reddy IlluminatorLuxtec Corp. · 1995
  • K895248IMS5000 Illuminated LoupesLuxtec Corp. · 1989
  • K890716Luxtec Aco Series 4000 Light SourceLuxtec Corp. · 1989
  • K864387Luxtec Fiberoptic CablesLuxtec Corp. · 19871 recall
  • K864382Frazier Suction TubeLuxtec Corp. · 1987

All 15 as Luxtec Corp. →

What has been recalled?

10 recalls linked to its devices; the latest:

  • K864380Luxtec UltraLite Headlight System with 9ft premium bifurcated cable Model: AX2100BIF…Oct 10, 2011
  • K864380Luxtec UltraLite Pro Headlight with 9ft bifurcated cable Model: AX2000BIF Product Usage…Oct 10, 2011
  • K864380Luxtec UltraLite Headlight System with short linkage Model: AX 1375BIFSL Product Usage…Oct 10, 2011
  • K864380Luxtec UltraLite Headlight System sweatband with short linkage Model: AXI385BIFSL…Oct 10, 2011
  • K864380UltraLite Headlight module-grey Model: 001328 Product Usage: The fiber optic headlight…Oct 10, 2011
  • K864380Luxtec UltraLite Headlight System Headband Model: AXI375BIF Product Usage: The fiber…Oct 10, 2011