Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009026057

FEI Number

3009026057

Entity Name

LENSAR, Inc

City/State/Country

Orlando, FL, US

Establishment Address

2800 Discovery Drive, Suite 100, Orlando, FL 32826, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LENSAR, Inc (Owner Number: 10041040)

Owner / Operator Contact Address

2800 Discovery Drive, Suite 100, Orlando, FL 32826, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K123859

PMA Number

N/A

All Registered Proprietary Names

LENSAR Laser System-fs 3D (LLS-fs 3D) Lensar Laser System-fs 3D (LLS-fs 3D) LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY LENSAR Laser System-fs 3D Lensar Laser System - fs 3D (LLS-fs 3D) LENSAR Laser System-fs 3D Lensar Laser System-fs 3D (LLS-fs 3D) LENSAR Laser System-fs 3D (LLS-fs 3D) ALLY Adaptive Cataract Treatment System LENSAR Laser System -fs 3D (LLS-fs 3D)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2018-04-13
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2018-04-13
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2012-06-14
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2012-06-14
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2012-08-10
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2012-08-10
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2018-08-17
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2018-08-17
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2012-12-07
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2019-01-07
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2012-08-10
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2012-08-10
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2016-09-21
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2016-09-21
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2017-10-16
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2017-10-16
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2022-06-22
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2017-10-16
HQC	Unit, Phacofragmentation	Ophthalmic	Class 2	886.4670	2017-10-16
HQF	Laser, Ophthalmic	Ophthalmic	Class 2	886.4390	2013-04-01
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2013-04-01

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LENSAR, Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K170322	Abbott Medical Optics, Inc.	Catalys Precision Laser System	2017-05-19
K091915	Lenstec, Inc.	FLUID ISOLATION DEVICE	2009-10-27
K830812	Alphamedix, Inc.	ALPHAMEDIX I/A HAND-PIECE, 500-001	1983-06-08
K133115	Abbott Medical Optics, Inc.	COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK	2014-02-27
K121721	Abbott Medical Optics, Inc.	LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)	2012-10-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-1515-2015	Abbott Medical Optics, Inc.	2	OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US). Product Usage: Indicated for use in patients undergoing cataract surgery for removal of crystalline lens.
Z-1670-2013	Abbott Medical Optics, Inc.	2	Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
Z-0099-2024	Alcon Research, LLC	2	Constellation Vision System, REF: 8065751150
Z-0305-2026	Alcon Research LLC	2	Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065750918 PAK,I/A LINE,NGVS 8065750957 ASSY,SHIP,CONSTELLATION VFC 8065750972 ENDOILLUMATOR,RFID,23G 8065751014 CONST AUTO GAS FILL PAK 8065751014 CONST AUTO GAS FILL PAK 8065751441 ENDOILLUMINATOR,RFID,25G 8065751577 CHANDELIER,25GA,W/RFID Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
Z-1794-2020	Alcon Research LLC	2	Alcon Constellation Vision System 20 GA TOTALPLUS Combined Procedure Pak, Product #8065751079, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009026057. Last updated year: 2026. Please use registration number 3009026057 when referencing this establishment in official correspondence.