Cleared Traditional

K964555 - VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S)

K964555 is an FDA 510(k) clearance for VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S), manufactured by Vitrotec, Inc.. The device is a Class 2 Ophthalmic device with product code MPA cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K964555 · Vitrotec, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
138d
Days
Class 2
Risk

K964555 is an FDA 510(k) clearance for the VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S). Classified as Endoilluminator (product code MPA), Class II - Special Controls.

Submitted by Vitrotec, Inc. (Chesterfield, US). The FDA issued a Cleared decision on March 31, 1997 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 876.1500 - 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 Vitrotec, Inc. devices

FDA 510(k) Submission Details - K964555

510(k) Number K964555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1996
Decision Date March 31, 1997
Days to Decision 138 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
28d slower than avg
Panel avg: 110d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MPA Device Classification - Class 2, Special Controls

Product Code MPA Endoilluminator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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.

Regulatory Peers - MPA Endoilluminator

All 24
Devices cleared under the same product code (MPA) and FDA review panel - the closest regulatory comparables to K964555.
MBI CO-AXIAL ILLUMINATED RETINAL PICK
K964553 · M.B. Industries, Inc. · May 1997
ENDOLIGHT FIBEROPTIC REGULAR MONOFILAMENT AND FINE MONOFILAMENT
K970878 · American Medical Devices, Inc. · May 1997
SYNTEC, INC. DISPOSABLE BARE END FIBER
K971338 · Syntec, Inc. · May 1997
INFINITECH LIGHTED INFUSION CANNULA
K946136 · Surgical Technologies, Inc. · Oct 1995