Cleared Traditional

SYLVAN PEDIASCAN 200 TRANSILLUMINATOR (K901309) - FDA 510(k) Clearance

Class I Ophthalmic device.

K901309 · Sylvan Corp. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1990
Decision
65d
Days
Class 1
Risk

K901309 is an FDA 510(k) clearance for the SYLVAN PEDIASCAN 200 TRANSILLUMINATOR. Classified as Transilluminator, Battery-powered (product code HJN), Class I - General Controls.

Submitted by Sylvan Corp. (Irwin, US). The FDA issued a Cleared decision on May 24, 1990 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1945 - the FDA ophthalmic 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 Sylvan Corp. devices

Submission Details

510(k) Number K901309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1990
Decision Date May 24, 1990
Days to Decision 65 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 110d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HJN Transilluminator, Battery-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1945
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.