Cleared Traditional

K861085 - ELASTIC LENS INJECTOR TM

K861085 is the FDA 510(k) clearance for ELASTIC LENS INJECTOR TM by Staar Surgical Co.. It is a Class 1 Ophthalmic device (product code KYB) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K861085 · Staar Surgical Co. · Ophthalmic device
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May 1986
Decision
68d
Days
Class 1
Risk

K861085 is an FDA 510(k) clearance for the ELASTIC LENS INJECTOR TM. Classified as Lens, Guide, Intraocular (product code KYB), Class I - General Controls.

Submitted by Staar Surgical Co. (Monrovia, US). The FDA issued a Cleared decision on May 28, 1986 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4300 - 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 Staar Surgical Co. devices

Submission Details

510(k) Number K861085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1986
Decision Date May 28, 1986
Days to Decision 68 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 110d · This submission: 68d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYB Lens, Guide, Intraocular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4300
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.

Regulatory Peers - KYB Lens, Guide, Intraocular

All 9
Devices cleared under the same product code (KYB) and FDA review panel - the closest regulatory comparables to K861085.
PASSPORT FOLDABLE LENS PLACEMENT SYSTEM
K951292 · Chiron Vision Corp. · Jun 1995
KRATZ NOVA-SERT
K871440 · CooperVision, Inc. · May 1987
KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR
K870265 · CooperVision, Inc. · Feb 1987
SURFACE REPLACEMENT HIP PROSTHESIS
K811718 · Biomet, Inc. · Sep 1981
CEMENT SPACERS
K791351 · Depuy, Inc. · Aug 1979