Cleared Traditional

K991479 - VISER PENILE TUMESCENCE MONITOR

K991479 · Laborie Medical Tech Corp. · Gastroenterology & Urology device
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Jul 1999
Decision
70d
Days
-
Risk

K991479 is an FDA 510(k) clearance for the VISER PENILE TUMESCENCE MONITOR. Classified as Monitor, Penile Tumescence (product code LIL).

Submitted by Laborie Medical Tech Corp. (Williston, US). The FDA issued a Cleared decision on July 7, 1999 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology 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: 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 Laborie Medical Tech Corp. devices

FDA 510(k) Submission Details - K991479

510(k) Number K991479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1999
Decision Date July 07, 1999
Days to Decision 70 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 131d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

LIL Device Classification - Class 0,

Product Code LIL Monitor, Penile Tumescence
Device Class -

Regulatory Peers - LIL Monitor, Penile Tumescence

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