Cleared Traditional

K981821 - VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR

K981821 is an FDA 510(k) clearance for VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR, manufactured by Angiolaz, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FSS cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K981821 · Angiolaz, Inc. · General & Plastic Surgery device
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Jul 1998
Decision
68d
Days
Class 2
Risk

K981821 is an FDA 510(k) clearance for the VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATOR. Classified as Light, Surgical, Floor Standing (product code FSS), Class II - Special Controls.

Submitted by Angiolaz, Inc. (Bellows Falls, US). The FDA issued a Cleared decision on July 29, 1998 after a review of 68 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - the FDA general and plastic surgery 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Angiolaz, Inc. devices

FDA 510(k) Submission Details - K981821

510(k) Number K981821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1998
Decision Date July 29, 1998
Days to Decision 68 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 115d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FSS Device Classification - Class 2, Special Controls

Product Code FSS Light, Surgical, Floor Standing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FSS Light, Surgical, Floor Standing

All 10
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