Cleared Traditional

K881499 - SURGILASE YAG 100 FOR GYNECOLOGY USE

K881499 is the FDA 510(k) clearance for SURGILASE YAG 100 FOR GYNECOLOGY USE by Surgilase, Inc.. It is a Class 2 Anesthesiology device (product code LLO) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K881499 · Surgilase, Inc. · Anesthesiology device
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Apr 1988
Decision
38d
Days
Class 2
Risk

K881499 is an FDA 510(k) clearance for the SURGILASE YAG 100 FOR GYNECOLOGY USE. Classified as Laser, Neodymium:yag, Pulmonary Surgery (product code LLO), Class II - Special Controls.

Submitted by Surgilase, Inc. (Warwick, US). The FDA issued a Cleared decision on April 29, 1988 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 874.4500 - the FDA anesthesiology and respiratory 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 Surgilase, Inc. devices

Submission Details

510(k) Number K881499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1988
Decision Date April 29, 1988
Days to Decision 38 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 140d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLO Laser, Neodymium:yag, Pulmonary Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4500
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 Anesthesiology devices follow this clearance model.