Cleared Traditional

ND:YAG LASER SPECTACLES, MST MODEL #YLS-5 (K883839) - FDA 510(k) Clearance

Class I General Hospital device.

K883839 · Marlo Surgical Technology · General Hospital
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Dec 1988
Decision
88d
Days
Class 1
Risk

K883839 is an FDA 510(k) clearance for the ND:YAG LASER SPECTACLES, MST MODEL #YLS-5. Classified as Snake Bite Suction Kit (product code KYP), Class I - General Controls.

Submitted by Marlo Surgical Technology (Willoughby, US). The FDA issued a Cleared decision on December 9, 1988 after a review of 88 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5740 - the FDA general hospital 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 Marlo Surgical Technology devices

Submission Details

510(k) Number K883839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1988
Decision Date December 09, 1988
Days to Decision 88 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 129d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYP Snake Bite Suction Kit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5740
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.