Cleared Traditional

HEADLAMP HL2000.

K994362 · Angiolaz, Inc. · Ophthalmic
May 2000
Decision
136d
Days
Class 2
Risk

About This 510(k) Submission

K994362 is an FDA 510(k) clearance for the HEADLAMP HL2000., a Light, Headband, Surgical (Class II — Special Controls, product code FSR), submitted by Angiolaz, Inc. (Bellows Falls, US). The FDA issued a Cleared decision on May 11, 2000, 136 days after receiving the submission on December 27, 1999. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4335.

Submission Details

510(k) Number K994362 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 1999
Decision Date May 11, 2000
Days to Decision 136 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code FSR — Light, Headband, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4335