Cleared Traditional

OMS SILICONE OIL INJECTOR (K844895) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K844895 · Optical Micro Systems, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1985
Decision
189d
Days
Class 3
Risk

K844895 is an FDA 510(k) clearance for the OMS SILICONE OIL INJECTOR. Classified as Fluid, Intraocular (product code LWL), Class III - Premarket Approval.

Submitted by Optical Micro Systems, Inc. (Danvers, US). The FDA issued a Cleared decision on June 24, 1985 after a review of 189 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4275 - 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: High-complexity regulatory submission. High regulatory complexity profile. 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 Optical Micro Systems, Inc. devices

Submission Details

510(k) Number K844895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1984
Decision Date June 24, 1985
Days to Decision 189 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 110d · This submission: 189d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LWL Fluid, Intraocular
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 886.4275
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.