Cleared Traditional

K935233 - IOLAB LACRIMAL DUCT CATHETER

K935233 · Chiron Vision Corp. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
318d
Days
-
Risk

K935233 is an FDA 510(k) clearance for the IOLAB LACRIMAL DUCT CATHETER. Classified as Lacrimal Stents And Intubation Sets (product code OKS).

Submitted by Chiron Vision Corp. (Irvine, US). The FDA issued a Cleared decision on September 15, 1994 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel. 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. Elevated predicate reliance 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.

FDA 510(k) Submission Details - K935233

510(k) Number K935233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1993
Decision Date September 15, 1994
Days to Decision 318 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
208d slower than avg
Panel avg: 110d · This submission: 318d
Pathway characteristics
Predicate-based equivalence.

OKS Device Classification - Class 0,

Product Code OKS Lacrimal Stents And Intubation Sets
Device Class -
Definition Lacrimal Stents And Intubations Sets Are Intended To Repair The Lacrimal Drainage System. Lacrimal Stents And Intubations Sets Are Indicated For, But Limited To, The Treatment Of Epiphora In Infants And Adults; Canalicular Pathologies Such As Stenosis; Obstruction Or Laceration; And Conditions Requiring Dacryocystorhinostomy (conventional Or Laser); Or Imperforation Of The Nasolacrimal Duct In An Infant.

Regulatory Peers - OKS Lacrimal Stents And Intubation Sets

All 30
Devices cleared under the same product code (OKS) and FDA review panel - the closest regulatory comparables to K935233.
ATRION MEDICAL COATED LACRIMAL INTUBATION SET
K973872 · Atrion Medical Products, Inc. · Jan 1998
RYDER LACRIMAL INTUBATIONSET
K962151 · Ryder Intl. Corp. · Sep 1996
RITLENG BICAN.LACR.SETS/SELF THREAD. MONOKAS(CHG.IN STER.)
K955671 · G.W.B. Intl., Ltd. · Mar 1996
OPHTA SIL (RITLENG PROBE AND LACRIMAL INTUBATION SET)
K940508 · G.W.B. Intl., Ltd. · May 1994
OPHTA SIL (R), LACHRYMAL INTUBATION SETS
K911109 · G.W.B. Intl., Ltd. · May 1991
EV MONOCANALICULAR STENT (TM)
K883233 · Eagle Vision, Inc. · Aug 1988
K935233 · IOLAB LACRIMAL DUCT CATHETER
Download PDF FDA Summary Chiron Vision Corp.