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Solid State Lamp [LED] Headlight

by Welch Allyn, Inc.

510(k) K031549

Solid State Lamp [LED] Headlight is a Class II device made by Welch Allyn, Inc., cleared under FDA 510(k) K031549 on 11 Aug 2003, active as of 11 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 11 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 11 Oct 2026.

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK031549 Date11 Aug 2003ClearedStatusActive

Official records

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  • Withdrawn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
FSR
Device class
Class II
Regulation
21 CFR Part 886.4335
Advisory committee
Ophthalmic
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code FSR (Light, Headband, Surgical).

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