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Luxtec Light Sources

by Luxtec Corp.

510(k) K864385

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK864385 Date13 Jan 1987ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0873-2007 FDA Unclassified (pre-2012) initiated 5 Apr 2007 on shared 510(k) K864385

    Incorrect power entry module assembled into unit may cause burning to insulation, compromised electrical emissions and premature light source failure

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FCW
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

A light source, fiberoptic, routine, classified as a Class II medical device under FDA regulation number 876.1500. It is designed to supply high intensity white light through a fiber optic cable for illumination of a surgical field.

Manufactured by Luxtec Corp. and cleared via the FDA 510(k) pathway (K864385) with a traditional submission. The device is intended for use in gastroenterology and urology settings, as indicated by the advisory committee classification. It is supplied as a reusable or reusable-compatible light source unit, with no sterility or single-use claims indicated in the provided data.

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