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Lutex Headlight Systems

by Luxtec Corp.

510(k) K864380

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

8 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK864380 Date19 Nov 1986ClearedStatusActive

Recalls

8 recalls · FDA

  • 8 recalls, same reason

    • Terminated Z-0373-2012 FDA Unclassified (pre-2012) initiated 10 Oct 2011
    • Terminated Z-0376-2012 FDA Unclassified (pre-2012) initiated 10 Oct 2011
    • Terminated Z-0378-2012 FDA Unclassified (pre-2012) initiated 10 Oct 2011
    • Terminated Z-0377-2012 FDA Unclassified (pre-2012) initiated 10 Oct 2011
    • Terminated Z-0381-2012 FDA Unclassified (pre-2012) initiated 10 Oct 2011
    • Terminated Z-0374-2012 FDA Unclassified (pre-2012) initiated 10 Oct 2011
    • Terminated Z-0380-2012 FDA Unclassified (pre-2012) initiated 10 Oct 2011
    • Terminated Z-0375-2012 FDA Unclassified (pre-2012) initiated 10 Oct 2011

    Headlight assembly (module) may become loose and separate from the headband assembly

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  • Withdrawn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
FST
Device Class
Class II
Regulation
21 CFR Part 878.4580
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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