Cleared Traditional

LM-150HT LIGHT SOURCE (K911212) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K911212 · Leisegang Medical, Inc. · Ear, Nose, Throat device
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May 1991
Decision
65d
Days
Class 3
Risk

K911212 is an FDA 510(k) clearance for the LM-150HT LIGHT SOURCE. Classified as Polymer, Natural-absorbable Gelatin Material (product code ESI), Class III - Premarket Approval.

Submitted by Leisegang Medical, Inc. (Boca Raton, US). The FDA issued a Cleared decision on May 23, 1991 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Leisegang Medical, Inc. devices

Submission Details

510(k) Number K911212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1991
Decision Date May 23, 1991
Days to Decision 65 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 89d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ESI Polymer, Natural-absorbable Gelatin Material
Device Class Class 3 - Premarket Approval
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.