Cleared Traditional

K994362 - HEADLAMP HL2000.

K994362 is an FDA 510(k) clearance for HEADLAMP HL2000., manufactured by Angiolaz, Inc.. The device is a Class 2 Ophthalmic device with product code FSR cleared through the Traditional 510(k) pathway after a 136-day FDA review.

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

K994362 is an FDA 510(k) clearance for the HEADLAMP HL2000.. Classified as Light, Headband, Surgical (product code FSR), Class II - Special Controls.

Submitted by Angiolaz, Inc. (Bellows Falls, US). The FDA issued a Cleared decision on May 11, 2000 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4335 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Angiolaz, Inc. devices

FDA 510(k) Submission Details - K994362

510(k) Number K994362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 110d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FSR Device Classification - Class 2, Special Controls

Product Code FSR Light, Headband, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4335
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.