Cleared Traditional

K121091 - CATALYS PRECISION LASER SYSTEM

K121091 is an FDA 510(k) clearance for CATALYS PRECISION LASER SYSTEM, manufactured by Optimedica Corporation. The device is a Class 2 Ophthalmic device with product code OOE cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K121091 · Optimedica Corporation · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
140d
Days
Class 2
Risk

K121091 is an FDA 510(k) clearance for the CATALYS PRECISION LASER SYSTEM. Classified as Ophthalmic Femtosecond Laser (product code OOE), Class II - Special Controls.

Submitted by Optimedica Corporation (Sunnyvale, US). The FDA issued a Cleared decision on August 28, 2012 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4390 - 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 Optimedica Corporation devices

FDA 510(k) Submission Details - K121091

510(k) Number K121091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2012
Decision Date August 28, 2012
Days to Decision 140 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
30d slower than avg
Panel avg: 110d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OOE Device Classification - Class 2, Special Controls

Product Code OOE Ophthalmic Femtosecond Laser
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4390
Definition Precise Cutting Or Ablation Of Ocular Tissue, Indicated For The Anterior Capsulotomy During Cataract Surgery.
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 Consultant

Johnson & Johnson Surgical Vision, Inc.
ALAN MARQUARDT

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.

Regulatory Peers - OOE Ophthalmic Femtosecond Laser

All 40
Devices cleared under the same product code (OOE) and FDA review panel - the closest regulatory comparables to K121091.
TBD
K123859 · Lensar, Inc. · Mar 2013
VICTUS FEMTOSECOND LASER PLATFORM
K122386 · Technolas Perfect Vision GmbH · Feb 2013
LENSX LASER SYSTEM
K123120 · Alcon Lensx, Inc. · Dec 2012
VICTUS LASER PLATFORM
K120426 · Technolas Perfect Vision GmbH · Jul 2012
TBD
K120214 · Lensar, Inc. · Jun 2012
OPTIMEDICA CATALYS PRECISION LASER SYSTEM
K113479 · Optimedica Corporation · Dec 2011