Cleared Traditional

K883213 - NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS) (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K883213 · Nidek, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1988
Decision
48d
Days
Class 2
Risk

K883213 is an FDA 510(k) clearance for the NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS). Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Nidek, Inc. (Palo Alto, US). The FDA issued a Cleared decision on September 15, 1988 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4390 - 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 Nidek, Inc. devices

Submission Details

510(k) Number K883213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1988
Decision Date September 15, 1988
Days to Decision 48 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 110d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HQF Laser, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4390
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 - HQF Laser, Ophthalmic

All 179
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K883213.
Voyager DSLT (430840610)
K252979 · Belkin Vision, Ltd. · Apr 2026
INTEGRE LIO
K251507 · Quantel Medical · Feb 2026
Navilas Laser System 577sl (156691)
K251772 · Od-Os GmbH · Oct 2025
EyeQ nanoECP
K243014 · Eyeq, Inc. · Jun 2025
Leos Laser and Endoscopy System
K240615 · Beaver-Visitec International, Inc. · Apr 2025
LYNX Photocoagulator
K242397 · Norlase Aps · Oct 2024