Cleared Traditional

K120214 - TBD

K120214 is an FDA 510(k) clearance for TBD, manufactured by Lensar, Inc.. The device is a Class 2 Ophthalmic device with product code OOE cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K120214 · Lensar, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2012
Decision
136d
Days
Class 2
Risk

K120214 is an FDA 510(k) clearance for the TBD. Classified as Ophthalmic Femtosecond Laser (product code OOE), Class II - Special Controls.

Submitted by Lensar, Inc. (Orlando, US). The FDA issued a Cleared decision on June 8, 2012 after a review of 136 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 Lensar, Inc. devices

FDA 510(k) Submission Details - K120214

510(k) Number K120214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2012
Decision Date June 08, 2012
Days to Decision 136 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
26d slower than avg
Panel avg: 110d · This submission: 136d
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 Peers - OOE Ophthalmic Femtosecond Laser

All 46
Devices cleared under the same product code (OOE) and FDA review panel - the closest regulatory comparables to K120214.
LENSX LASER SYSTEM
K123120 · Alcon Lensx, Inc. · Dec 2012
CATALYS PRECISION LASER SYSTEM
K121091 · Optimedica Corporation · Aug 2012
VICTUS LASER PLATFORM
K120426 · Technolas Perfect Vision GmbH · Jul 2012
OPTIMEDICA CATALYS PRECISION LASER SYSTEM
K113479 · Optimedica Corporation · Dec 2011
FEMTEC LASER SYSTEM FOR CAPSULOTOMY
K110427 · Technolas Perfect Vision GmbH · Nov 2011
TBD
K112098 · Lensar, Inc. · Oct 2011