Cleared Traditional

BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080 (K000544) - FDA 510(k) Clearance

Class I Ophthalmic device.

K000544 · Labtician Ophthalmics, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
20d
Days
Class 1
Risk

K000544 is an FDA 510(k) clearance for the BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080. Classified as Reader, Prism, Ophthalmic (product code HJX), Class I - General Controls.

Submitted by Labtician Ophthalmics, Inc. (Oakville, Ontario, CA). The FDA issued a Cleared decision on March 9, 2000 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5810 - 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 Labtician Ophthalmics, Inc. devices

Submission Details

510(k) Number K000544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2000
Decision Date March 09, 2000
Days to Decision 20 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 110d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HJX Reader, Prism, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5810
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.