← Product Code [OOE](/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE) · K182795
# LENSAR Laser System - fs 3D (LLS-fs 3D) (K182795)
_Lensar, Inc. · OOE · Dec 21, 2018 · Ophthalmic · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K182795
## Device Facts
- **Applicant:** Lensar, Inc.
- **Product Code:** [OOE](/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE.md)
- **Decision Date:** Dec 21, 2018
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.4390
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic
- **Attributes:** Therapeutic
## Intended 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.
## Regulatory 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](/device/K181430.md))
- WaveLight® FS200 Laser System ([K141476](/device/K141476.md))
## Submission Summary (Full Text)
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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
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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
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# 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)
| ☑ Prescription Use (Part 21 CER 801 Subpart D)
|
|---------------------------------------------------------------------------------------------------------------|
| ☐ Over-The-Counter Use (21 CER 801 Subpart C)
|
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# 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
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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.
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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…
---
**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K182795](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K182795)
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