Cleared Traditional

K934269 - FIBEROPTIC ILLUMINATED INSTRUMENTS

K934269 is an FDA 510(k) clearance for FIBEROPTIC ILLUMINATED INSTRUMENTS, manufactured by Visitec Co.. The device is a Class 2 Ophthalmic device with product code HJM cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K934269 · Visitec Co. · Ophthalmic device
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May 1994
Decision
259d
Days
Class 2
Risk

K934269 is an FDA 510(k) clearance for the FIBEROPTIC ILLUMINATED INSTRUMENTS. Classified as Transilluminator, Ac-powered (product code HJM), Class II - Special Controls.

Submitted by Visitec Co. (Sarasota, US). The FDA issued a Cleared decision on May 17, 1994 after a review of 259 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Visitec Co. devices

FDA 510(k) Submission Details - K934269

510(k) Number K934269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1993
Decision Date May 17, 1994
Days to Decision 259 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
149d slower than avg
Panel avg: 110d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HJM Device Classification - Class 2, Special Controls

Product Code HJM Transilluminator, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1945
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.