Who is the manufacturer of LENSAR Laser System - fs 3D (LLS-fs 3D)?

Lensar, Inc. filed the 510(k) submission for LENSAR Laser System - fs 3D (LLS-fs 3D) (K182795).

What is the FDA product code for LENSAR Laser System - fs 3D (LLS-fs 3D)?

OOE. It is classified under 21 CFR 886.4390 as a Class 2 device in the Ophthalmic panel.

What is the regulatory pathway for LENSAR Laser System - fs 3D (LLS-fs 3D)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for LENSAR Laser System - fs 3D (LLS-fs 3D)?

LENSAR Laser System - fs 3D (LLS-fs 3D) (K181430); WaveLight® FS200 Laser System (K141476).

Who can help prepare an FDA 510(k) submission like LENSAR Laser System - fs 3D (LLS-fs 3D)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

LENSAR Laser System - fs 3D (LLS-fs 3D)

K182795 · Lensar, Inc. · OOE · Dec 21, 2018 · Ophthalmic

Device Facts

Record ID	K182795
Device Name	LENSAR Laser System - fs 3D (LLS-fs 3D)
Applicant	Lensar, Inc.
Product Code	OOE · Ophthalmic
Decision Date	Dec 21, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 886.4390
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The LENSAR Laser System - fs 3D (LLS-fs 3D) with Streamline™ is an ophthalmic surgical laser indicated for use: · in the creation of an anterior capsulotomy; - · in patients undergoing surgery requiring laser-assisted fragmentation of the cataractous lens; - · in the creation of full and partial thickness single-plane arc cuts/incisions in the cornea; - · in patients undergoing ophthalmic surgery or other treatments requiring pocket cuts/ incisions in the cornea; - · in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea; - · in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; and - · in the creation of partial thickness single-plane radial cuts/incisions in the cornea.

Device Story

Ophthalmic surgical laser system; utilizes pulsed Yb:YAG laser (1030 nm) for photodisruption and plasma-mediated ablation. Inputs: pre-operative clinical data; 3D-CSI imaging (Scheimpflug camera-based). Operation: surgeon-driven, computer-controlled scanner with F-theta lens; automated Iris Registration with cyclorotation adjustment; IntelliAxis markers for Toric IOL alignment. Outputs: precision capsulotomy; lens fragmentation; corneal incisions (arc, radial, pocket, flap, tunnels). Used in clinical settings by ophthalmologists. System provides graphical guidance and templates; surgeon confirms planning and positioning at each step. Benefits: automated precision control of incision size, architecture, and location; improved alignment for IOLs; standardized cataract fragmentation.

Clinical Evidence

No clinical data. Bench testing only. Porcine ex vivo eye models used to validate corneal tunnel depth accuracy, radial/arcuate incision depth, and incision quality. Endothelial cell density impact evaluated in previous studies. Hazard analysis performed for all changes.

Technological Characteristics

Yb:YAG laser (1030 nm); mode-locked; 20-80 kHz repetition rate; 1.5 ps pulse duration; 15 µJ max pulse energy. 3D Confocal Structured Illumination (3D-CSI) imaging. Disposable polycarbonate/silicone patient interface. Gamma/EO sterilization. Computer-controlled scanner. Software-based guidance and iris registration.

Indications for Use

Indicated for patients undergoing ophthalmic surgery requiring anterior capsulotomy, laser-assisted cataract lens fragmentation, corneal pocket/flap creation, lamellar resection for corneal ring segment tunnels, or single-plane arc/radial corneal incisions.

Regulatory Classification

Identification

An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.

Predicate Devices

LENSAR Laser System - fs 3D (LLS-fs 3D) (K181430)
WaveLight® FS200 Laser System (K141476)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue. December 21, 2018 Lensar, Inc. Keith Peck Director, Quality Assurance 2800 Discovery Drive. Suite 100 Orlando, FL 32826 Re: K182795 Trade/Device Name: LENSAR Laser System - fs 3D (LLS-fs 3D) Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: OOE Dated: September 28, 2018 Received: October 1, 2018 Dear Keith Peck: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Bradley S. Cunningham -S for Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K182795 Device Name LENSAR Laser System - fs 3D ### Indications for Use (Describe) The LENSAR Laser System - fs 3D (LLS-fs 3D) with Streamline™ is an ophthalmic surgical laser indicated for use: · in the creation of an anterior capsulotomy; - · in patients undergoing surgery requiring laser-assisted fragmentation of the cataractous lens; - · in the creation of full and partial thickness single-plane arc cuts/incisions in the cornea; - · in patients undergoing ophthalmic surgery or other treatments requiring pocket cuts/ incisions in the cornea; - · in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea; - · in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; and - · in the creation of partial thickness single-plane radial cuts/incisions in the cornea. Type of Use (Select one or both, as applicable) | <div> ☑ Prescription Use (Part 21 CER 801 Subpart D) </div> | |---------------------------------------------------------------------------------------------------------------| | <div> ☐ Over-The-Counter Use (21 CER 801 Subpart C) </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(K) SUMMARY This 510(k) Summary has been prepared in accordance with the requirements of 21 CFR 807.92. #### SUBMITTER INFORMATION 1.0 The submitter of this 510(k) Summary is: | Company: | Contact Person: | |----------------------------------------------------------------------|--------------------------------------------------------------| | LENSAR, Inc. 2800 Discovery Drive, Suite 100 Orlando, FL 32826 | Keith Peck (888) 575-6412 (Office (407) 386-7228 (Fax) | Summary Preparation Date: December 21, 2018 #### DEVICE INFORMATION 2.0 | | Trade/Proprietary Name: LENSAR Laser System - fs 3D (LLS-fs 3D) | |-------------------------|-----------------------------------------------------------------| | Common/Usual Name: | Ophthalmic Femtosecond Laser | | Classification Name(s): | Ophthalmic Femtosecond Laser (21 CFR 886.4390) | | Product Code(s): | OOE | | Review Panel: | Ophthalmic | | Regulatory Class: | II | #### 3.0 PREDICATE DEVICE The legally marketed (predicate) device to which LENSAR is claiming substantial equivalence to is: | 510(k) Number | Device Name | Manufacturer | |---------------|---------------------------------------------------------------------------------|--------------------------| | K181430 | LENSAR Laser System - fs 3D (LLS-fs 3D) (for use in radial cuts/incisions) | LENSAR, Inc. | | K141476 | WaveLight® FS200 Laser System (for use in tunnels for corneal ring segments) | Alcon Laboratories, Inc. | #### 4.0 DEVICE DESCRIPTION The LLS-fs 3D with Streamline™ is a medical device for use in ophthalmic surgery. The device utilizes a pulsed laser that can be used to cut a precision capsulotomy in the anterior lens capsule, to fragment the cataractous lens for removal during cataract surgery, and to create full and partial thickness single-plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. The device is also intended for use in the creation of pocket cuts/incisions in the cornea in patients undergoing ophthalmic surgery, in the creation of a corneal flap in patients undergoing treatment requiring {4}------------------------------------------------ initial lamellar resection of the cornea, and in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments, each of which may only be performed individually. Additionally, the device is also intended for use in the creation of partial thickness single-plane radial cuts/incisions in the cornea which may be performed individually or consecutively with arcuate incisions. Use of the laser provides automated precision control of the size of the capsular opening; the type and parameters of laser fragmentation treatment within the lens; the size, architecture, and location of full thickness incisions within the cornea; the size, architecture, location, depth, and quantity of partial thickness incisions within the cornea; and the size, architecture, and depth of pocket. flap, and tunnel cuts. The LLS-fs 3D with Streamline™ includes the integration with pre-op analysis devices, automated Iris Registration with automatic cyclorotation adjustment, IntelliAxis-C™ (corneal) and IntelliAxis-L™ (lens) markers for simple alignment of Toric IOLs as well as treatment planning tools for precision-guided laser treatments. #### 5.0 INDICATIONS FOR USE The LENSAR Laser System – fs 3D (LLS-fs 3D) with Streamline™ is an ophthalmic surgical laser indicated for use: - in the creation of an anterior capsulotomy; ● - in patients undergoing surgery requiring laser-assisted fragmentation of the cataractous lens: - . in the creation of full and partial thickness single-plane arc cuts/incisions in the cornea; - in patients undergoing ophthalmic surgery or other treatments requiring pocket cuts/ incisions in the cornea; - in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea; - . in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; and - in the creation of partial thickness single-plane radial cuts/incisions in the cornea ### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE 6.0 PREDICATE DEVICE All elements of the proposed device remain unchanged from that cleared under K181430 except for the following technological difference: - addition of a new indication for use in patients undergoing surgery or other treatments . requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments: and - . addition of a new indication for the creation of partial thickness single-plane radial cuts/incisions in the cornea. {5}------------------------------------------------ Other changes unrelated to the requested change for the addition of the new indications are as follows: - . allowing arcuate incisions that are currently cleared to be completed with the curved contact patient interface device (PID) that is already cleared; - . the ability to manually adjust the location of the capsulotomy without compromising the safety limits to the iris that already exist; and - . the ability to fragment the lens closer to the anterior capsule only within the boundaries of the capsulotomy diameter. The following table provides a comparative between the proposed LLS-fs 3D laser device with the addition of the new indications and the predicate laser devices. | Table 1: Summary of Technological Characteristics | | | | |----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristics | Proposed Device LLS-fs 3D Laser System 510(k) K182795 | Predicate Device (Radial Cuts/Incisions) LLS-fs 3D Laser System 510(k) K181430 Cleared: 08/09/2018 | Predicate Device (Tunnels for Corneal Ring Segments) WaveLight FS200 Laser System 510(k) K141476 Cleared: 09/30/2014 | | Indication for Use | The LENSAR Laser System - fs 3D (LLS-fs 3D) with Streamline™ is an ophthalmic surgical laser indicated for use: in the creation of an anterior capsulotomy;in patients undergoing surgery requiring laser-assisted fragmentation of the cataractous lens;in the creation of full and partial thickness single-plane and multi- plane arc cuts/ incisions in the cornea;in patients undergoing ophthalmic surgery or other treatments requiring pocket cuts/incisions in the cornea;in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea; | The LENSAR Laser System - fs 3D (LLS-fs 3D) with Streamline™ is an ophthalmic surgical laser indicated for use: in the creation of an anterior capsulotomy;in patients undergoing surgery requiring laser-assisted fragmentation of the cataractous lens;in the creation of full and partial thickness single-plane and multi- plane arc cuts/ incisions in the cornea;in patients undergoing ophthalmic surgery or other treatments requiring pocket cuts/incisions in the cornea;in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea. | The WaveLight FS200 Laser System is an ophthalmic surgical laser indicated for use: In the creation of a corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea.In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments.In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty.In the creation of a penetrating cut/incision for penetrating keratoplasty and for corneal harvesting.In patients undergoing ophthalmic surgery or other treatment requiring arcuate cuts/ incisions in the cornea.In patients undergoing ophthalmic surgery or other treatment requiring pocket cuts/ incisions in the cornea. | | Table 1: Summary of Technological Characteristics | | | | | Characteristics | Proposed Device LLS-fs 3D Laser System 510(k) K182795 | Predicate Device (Radial Cuts/Incisions) LLS-fs 3D Laser System 510(k) K181430 Cleared: 08/09/2018 | Predicate Device (Tunnels for Corneal Ring Segments) WaveLight FS200 Laser System 510(k) K141476 Cleared: 09/30/2014 | | | in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; and in the creation of partial thickness single-plane radial cuts/incisions in the cornea. | | | | Operating Principle | Photodisruption and plasma mediated ablation | Photodisruption and plasma mediated ablation | Photodisruption and plasma mediated ablation | | Lens Fragmentation Removal | Provided by commercially available separate system of ultrasound; irrigation/ aspiration | Provided by commercially available separate system of ultrasound; irrigation/ aspiration | Provided by commercially available separate system of ultrasound; irrigation/ aspiration | | Class/ Product Code/ Regulation | Class II/ OOE/ 886.4390 | Class II/ OOE/ 886.4390 | Class II/ OOE/ 886.4390 | | Patient Contact Portion of Device | Disposable polycarbonate/ silicone patient interface accessory; suction ring assembly | Disposable polycarbonate/ silicone patient interface accessory; suction ring assembly | Disposable patient contact consumable accessory; suction ring assembly and applanating cone. | | Sterilization Method (patient interface accessory) | Gamma irradiation (not including Curved Contact PID) or Ethylene Oxide (EO) | Gamma irradiation (not including Curved Contact PID) or Ethylene Oxide (EO) | Ethylene Oxide (EO) | | Laser Type | Yb:YAG | Yb:YAG | Nd:Glass* | | Wavelength | 1030 nm | 1030 nm | 1030 nm | | Pulsing | Mode-locked | Mode-locked | Mode-locked | | Mode | Fundamental (TEM00) | Fundamental (TEM00) | Fundamental (TEM00) | | Pulse Duration | $1.5 x10^{-12}$ sec | $1.5 x10^{-12}$ sec | $0.35 x 10^{-12}$ sec | | Repetition Rate | 20-80 kHz, adjustable | 20-80 kHz, adjustable | 200 kHz | | Maximum Pulse Energy | 15 µJ | 15 µJ | 2.4 µJ | | Maximum Peak Power | 9 MW | 9 MW | 7 MW | | Table 1: Summary of Technological Characteristics | | | | | Characteristics | Proposed Device LLS-fs 3D Laser System 510(k) K182795 | Predicate Device (Radial Cuts/Incisions) LLS-fs 3D Laser System 510(k) K181430 Cleared: 08/09/2018 | Predicate Device (Tunnels for Corneal Ring Segments) WaveLight FS200 Laser System 510(k) K141476 Cleared: 09/30/2014 | | Biometrics | Scheimpflug Camera- based Imaging System with 3D Confocal Structured Illumination (3D-CSI) | Scheimpflug Camera- based Imaging System with 3D Confocal Structured Illumination (3D-CSI) | Opto-Mechanical referencing | | Beam Targeting and Delivery | Computer-controlled scanner with F-theta lens | Computer-controlled scanner with F-theta lens | Computer-controlled scanner with F-theta lens | | Photodisruptive Fluence Threshold in Lens Tissue | 4 J/cm² | 4 J/cm²…

LENSAR Laser System - fs 3D (LLS-fs 3D)

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

LENSAR Laser System - fs 3D (LLS-fs 3D)

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Connected apps

Welcome

Check your email

Welcome!