Solid State Lamp [Led] Headlight

Q: What is the product code of K031549?

The FDA product code is FSR – Light, Headband, Surgical, a Class II (moderate risk) device regulated under 21 CFR 886.4335.

FDA 510(k) K031549 · Welch Allyn, Inc.

Substantially Equivalent

510(k) numberK031549

Submission

Device name: Solid State Lamp [Led] Headlight
Applicant: Welch Allyn, Inc.
Skaneateles Falls, NY, US
Received: May 16, 2003
Decision date: August 11, 2003
Decision: Substantially Equivalent (SESE)
Type: Abbreviated 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: FSR – Light, Headband, Surgical
Device class: Class II (moderate risk)
Regulation: 21 CFR 886.4335
Specialty: Ophthalmic

Other 510(k)s with product code FSR

510(k)	Device	Applicant	Decision
K110528	Integra LED Surgical Headlight SystemFSR · Traditional	Integra LifeSciences Corporation	05/11/2011SE
K031548	LED HeadlightFSR · Abbreviated	Welch Allyn, Inc.	08/11/2003SE
K994362	Headlamp HL2000.FSR · Traditional	Angiolaz, Inc.	05/11/2000SE

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Questions and answers

When was Solid State Lamp [Led] Headlight cleared by the FDA?

Solid State Lamp [Led] Headlight (K031549) received a 510(k) decision of Substantially Equivalent on August 11, 2003, 87 days after the submission was received.

What is the product code of K031549?

The FDA product code is FSR – Light, Headband, Surgical, a Class II (moderate risk) device regulated under 21 CFR 886.4335.