Cleared Traditional

K870265 - KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR

K870265 is an FDA 510(k) clearance for KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS ..., manufactured by CooperVision, Inc.. The device is a Class 1 Ophthalmic device with product code KYB cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K870265 · CooperVision, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1987
Decision
28d
Days
Class 1
Risk

K870265 is an FDA 510(k) clearance for the KRATZ NOVA-SERT. SOFT INTRAOCULAR LENS INJECTOR. Classified as Lens, Guide, Intraocular (product code KYB), Class I - General Controls.

Submitted by CooperVision, Inc. (Bellevue, US). The FDA issued a Cleared decision on February 20, 1987 after a review of 28 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 CooperVision, Inc. devices

FDA 510(k) Submission Details - K870265

510(k) Number K870265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1987
Decision Date February 20, 1987
Days to Decision 28 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 110d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

KYB Device Classification - Class 1, General Controls

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 19
Devices cleared under the same product code (KYB) and FDA review panel - the closest regulatory comparables to K870265.
MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION)
K954600 · Staar Surgical Co. · Dec 1995
PASSPORT FOLDABLE LENS PLACEMENT SYSTEM
K951292 · Chiron Vision Corp. · Jun 1995
KRATZ NOVA-SERT
K871440 · CooperVision, Inc. · May 1987
SOFT LENS FOLDER
K861990 · Staar Surgical Co. · Jun 1986
ELASTIC LENS INJECTOR TM
K861085 · Staar Surgical Co. · May 1986
MAZZOCCO/FRENCHIK FOLDER
K860148 · Staar Surgical Co. · Mar 1986