Headlamp HL2000.

FDA 510(k) K994362 · Angiolaz, Inc.

Substantially Equivalent

510(k) numberK994362

Submission

Device name
Headlamp HL2000.
Applicant
Angiolaz, Inc.
Bellows Falls, VT, US
Received
December 27, 1999
Decision date
May 11, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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

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Questions and answers

When was Headlamp HL2000. cleared by the FDA?

Headlamp HL2000. (K994362) received a 510(k) decision of Substantially Equivalent on May 11, 2000, 136 days after the submission was received.

What is the product code of K994362?

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