Cleared Traditional

K201892 - Ritleng®+ and Ritleng®+ PVP (FDA 510(k) Clearance)

K201892 · Fci (France Chirurgie Instrumentation) Sas · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2021
Decision
246d
Days
-
Risk

K201892 is an FDA 510(k) clearance for the Ritleng®+ and Ritleng®+ PVP. Classified as Lacrimal Stents And Intubation Sets (product code OKS).

Submitted by Fci (France Chirurgie Instrumentation) Sas (Paris, FR). The FDA issued a Cleared decision on March 11, 2021 after a review of 246 days - an extended review cycle.

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. Standard predicate reliance. 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 Fci (France Chirurgie Instrumentation) Sas devices

Submission Details

510(k) Number K201892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 2020
Decision Date March 11, 2021
Days to Decision 246 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
136d slower than avg
Panel avg: 110d · This submission: 246d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 Consultant

Clinical Research Consultants, Inc.
Barbara S. Fant

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.