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LED Headlight

by Welch Allyn, Inc.

510(k) K031548

LED Headlight is a Class II device made by Welch Allyn, Inc., cleared under FDA 510(k) K031548 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 NumberK031548 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  • Withdrawn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

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K031548

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K031548
UDI-DISize and differences
Welch Allyn, Inc. 901067
Welch Allyn, Inc.
44900-C / 90106700732094004571 —On the market
Welch Allyn, Inc. 901067
Welch Allyn, Inc.
44900-W / 90106700732094004564 —On the market

Similar devices

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

Other devices from Welch Allyn, Inc.

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