Cleared Traditional

K192113 - DRSplus

K192113 is an FDA 510(k) clearance for DRSplus, manufactured by Centervue S.P.A.. The device is a Class 2 Ophthalmic device with product code MYC cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K192113 · Centervue S.P.A. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2019
Decision
102d
Days
Class 2
Risk

K192113 is an FDA 510(k) clearance for the DRSplus. Classified as Ophthalmoscope, Laser, Scanning (product code MYC), Class II - Special Controls.

Submitted by Centervue S.P.A. (Padova, IT). The FDA issued a Cleared decision on November 15, 2019 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - 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: 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 Centervue S.P.A. devices

FDA 510(k) Submission Details - K192113

510(k) Number K192113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2019
Decision Date November 15, 2019
Days to Decision 102 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
8d faster than avg
Panel avg: 110d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MYC Device Classification - Class 2, Special Controls

Product Code MYC Ophthalmoscope, Laser, Scanning
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - MYC Ophthalmoscope, Laser, Scanning

All 8
Devices cleared under the same product code (MYC) and FDA review panel - the closest regulatory comparables to K192113.
MAIA (AHMACME001)
K243504 · Centervue S.P.A. · Mar 2025
DRSplus
K213705 · Centervue S.P.A. · Dec 2021
EIDON FA, EIDON, EIDON AF, EIDON UWFL
K211328 · Centervue S.P.A. · Aug 2021
EIDON FA
K180526 · Centervue S.P.A. · Jul 2018
Retia 2
K180293 · Centervue S.P.A. · May 2018
GDXPRO
K093521 · Carl Zeiss Meditec, Inc. · Nov 2009