Cleared Traditional

K853927 - LASE SYSTEM II (FDA 510(k) Clearance)

K853927 · James L. Geraci & Associates, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1985
Decision
22d
Days
-
Risk

K853927 is an FDA 510(k) clearance for the LASE SYSTEM II.

Submitted by James L. Geraci & Associates, Inc. (Cincinnati, US). The FDA issued a Cleared decision on October 16, 1985 after a review of 22 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery 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 James L. Geraci & Associates, Inc. devices

Submission Details

510(k) Number K853927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1985
Decision Date October 16, 1985
Days to Decision 22 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 114d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -