(131 days)
The LenSx Laser system is indicated for use:
- In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate), anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery.
- In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate) during Implantable Collamer Lens (ICL) surgery.
- In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
- In the creation of corneal pockets for placement/insertion of a corneal inlay device; and for creation of corneal tunnels for the placement of corneal rings.
The LenSx Laser system is an ophthalmic surgical laser which uses focused femtosecond laser pulses to create vapor bubbles which disrupts/separates tissue (photodisruption) within the lens capsule, crystalline lens, and the cornea. A computer-guided delivery system places the laser pulses in a pattern to produce an incision/cut.
The laser pulses are delivered through a sterile, disposable applanating lens and suction ring that contacts the cornea and fixes the eye with respect to the laser delivery system.
The interface between the laser and patient is the Patient Interface that connects to the delivery system which is docked to the patient's cornea. Two models of the Patient Interface accessory are offered for use with the LenSx Laser: the LenSx Laser Patient Interface and the LenSx Laser SoftFit Patient Interface. Both models consist of a sterile, disposable applanating lens and suction ring assembly. The LenSx Laser SoftFit Patient Interface also comes with a soft contact lens that is positioned against the external surface of the Patient Interface glass. For cataract procedures, the LenSx Laser SoftFit Patient Interface is used. The LenSx Laser Patient Interface is used for corneal, flap, tunnel, and pocket incisions. Refer to the Instructions for Use supplied with the LenSx Laser Patient Interface for preparation and application.
The LenSx Laser system is for prescription use and should only be operated by a trained physician. The LenSx Laser system is intended to be used within a clinic(s)/hospital(s)/surgical practice network.
Based on the provided FDA 510(k) Clearance Letter for the LenSx Laser System, this document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance data for a new AI or novel diagnostic device.
The clearance is for a modified version of an existing device (LenSx Laser System) with software updates and an expanded indication for Implantable Collamer Lens (ICL) surgery. The general approach taken is to show that these modifications do not raise new questions of safety or efficacy and that the device remains substantially equivalent to its predicate. Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria (especially in the context of an AI/diagnostic device) is not explicitly detailed in this 510(k) summary.
However, I can extract the relevant information presented, acknowledging that it's framed within the context of demonstrating substantial equivalence for a modified device, rather than a de novo clearance for a completely new technology with novel performance claims.
Here's an attempt to answer the questions based on the provided text, highlighting where the information is not applicable or not detailed in this type of submission:
Acceptance Criteria and Device Performance Study (as inferred from the 510(k) Summary)
The 510(k) summary indicates that the modifications to the LenSx Laser System are minor and do not introduce new safety or efficacy concerns. The "acceptance criteria" are implied by the successful completion of various non-clinical tests demonstrating that the device continues to meet its intended design specifications and functional requirements, performing as intended and being equivalent to the predicate. There are no specific numerical performance metrics provided in the summary that would typically be seen for a new diagnostic or AI device (e.g., sensitivity, specificity, accuracy against a gold standard).
Table of Acceptance Criteria and Reported Device Performance
Since this is a modification to an existing device, the "acceptance criteria" are generally about maintaining the performance and safety profiles of the predicate. The "reported device performance" refers to the successful completion of the tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Non-Clinical Testing: | |
| Biocompatibility requirements per ISO 10993-1. | No further testing required; materials are common and widely used. |
| Sterilization and Shelf Life. | Console provided non-sterile; intended for use with sterile accessories. |
| Electromagnetic Compatibility (EMC) according to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60601-4-2, and FDA guidance. | Met all requirements and followed FDA recommendations. |
| Electrical/Mechanical Safety according to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60601-4-2. | Met all requirements. |
| Optical Radiation Safety according to ANSI Z80.36-2021. | Retinal exposures in compliance with limits for Group 1 devices. |
| Software Verification and Validation. | Successfully completed and met all requirements; documentation provided as recommended by FDA guidance ("Enhanced Documentation Level"). |
| Cybersecurity compliance per FDA guidance. | Fulfilled FDA's cybersecurity recommendations. |
| Performance Testing (bench testing, design specifications, functional requirements). | Successfully completed bench testing; demonstrated ability to meet all intended design specifications. Features (including new ones like arcuate nomogram, phacofragmentation patterns, capsulorhexis markers, ICL setting) function as intended and meet applicable design requirements. Performance regression and toric markings capsular bag pull tests were successful. |
| Equivalence Criteria: | |
| No new questions of safety and efficacy compared to predicate. | Determined to be substantially equivalent to the predicate device. |
| Risk profile equivalent to the predicate device. | Risk profiles are equivalent. |
| Maintain functional requirements. | Functional requirements were met. |
Study Details (as applicable)
-
Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not specified in terms of clinical cases or patient data, as no animal or clinical testing was deemed necessary for this submission. The "test set" primarily refers to bench testing, software verification/validation, and regulatory compliance checks.
- Data Provenance: Not applicable as no clinical or animal data was collected for this submission. The data provenance for compliance testing is internal Alcon laboratories.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this 510(k) submission does not rely on expert-adjudicated ground truth from a clinical test set. The ground truth for engineering and software tests is based on design specifications, recognized standards, and regulatory guidance. For clinical ground truth, the submission relies on the established safety and efficacy of the predicate device and the assessment that the modifications do not alter this.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There was no clinical test set requiring expert adjudication.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was performed or required. The device is a surgical laser, not an AI-assisted diagnostic tool that would typically involve human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of an AI algorithm. However, the device itself, including its software, undergoes standalone functional and safety testing as part of the "Non-Clinical Testing" detailed in Section 7.1, such as "Software verification and validation testing" and "Performance Testing." These tests ensure the device (algorithm and hardware) performs its functions correctly according to specifications, independent of operator interaction after initial surgical planning.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For the non-clinical and software testing, the "ground truth" is defined by:
- Engineering Specifications: The pre-defined technical and functional requirements for the laser system.
- International and National Standards: Compliance with standards like IEC 60601 series, ANSI Z80.36-2021 for safety and performance.
- FDA Guidance Documents: Compliance with FDA recommendations for software documentation and cybersecurity.
- Predicate Device Performance: The established safety and effectiveness of the existing LenSx Laser System serves as the clinical benchmark.
- For the non-clinical and software testing, the "ground truth" is defined by:
-
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that relies on a "training set" of data in the typical sense for a new diagnostic algorithm. The software modifications are deterministic or rule-based enhancements (e.g., embedded calculator, new cut patterns).
-
How the ground truth for the training set was established:
- Not applicable for the same reason as above. If there were internal development/optimization processes for the new features (e.g., nomogram calculations), their accuracy and "ground truth" would be established through mathematical validation, simulation, and bench testing against known physical principles or desired outcomes, rather than a data-driven training set.
FDA 510(k) Clearance Letter - LenSx Laser System
Page 1
April 28, 2025
Alcon Laboratories, Inc.
Tammy Vu
Regulatory Affairs Associate Director
6201 South Freeway
Fort Worth, Texas 76134-2099
Re: K243896
Trade/Device Name: LenSx Laser System (8065998162)
Regulation Number: 21 CFR 886.4390
Regulation Name: Ophthalmic Laser
Regulatory Class: Class II
Product Code: OOE, HQC, HNO
Dated: March 21, 2025
Received: March 24, 2025
Dear Tammy Vu:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/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.
Page 2
K243896 - Tammy Vu Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
Page 3
K243896 - Tammy Vu Page 3
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
CLAUDINE H. KRAWCZYK -S
Claudine Krawczyk
Assistant Director
DHT1A: Division of Ophthalmic Devices
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
| Submission Number (if known) | K243896 |
|---|---|
| Device Name | LenSx Laser System (8065998162) |
Indications for Use (Describe)
The LenSx Laser system is indicated for use:
-
In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate), anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery.
-
In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate) during Implantable Collamer Lens (ICL) surgery.
-
In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
-
In the creation of corneal pockets for placement/insertion of a corneal inlay device; and for creation of corneal tunnels for the placement of corneal rings.
Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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."
Page 5
510(k)# K243896 510(k) Summary: LenSx Laser System
Page 1 of 6
In accordance with 21 CFR 807.92, Alcon hereby provides the 510(k) summary for the LenSx Laser system.
1. SUBMITTER [per 807.92(a)(1)]
| Applicant | Alcon Laboratories, Inc.6201 South FreewayFort Worth, TX 76134-2099 |
|---|---|
| Primary Correspondent | Tammy VuAssociate Director, Regulatory AffairsAlcon Research LLC, on behalf of Alcon Laboratories, Inc.20511 Lake Forest DriveLake Forest, CA 92630-7741+1 (949) 505-7519tammy.vu@alcon.com |
| Secondary Correspondent | Ophelia BiggsSenior Director, Regulatory AffairsAlcon Research LLC, on behalf of Alcon Laboratories, Inc.20511 Lake Forest DriveLake Forest, CA 92630-7741+1 (949) 505-7557ophelia.biggs@alcon.com |
| Date Prepared | April 22, 2025 |
2. SUBJECT DEVICE [per 807.92(a)(2)]
| Device Trade Name | LenSx Laser System (8065998162) |
|---|---|
| Regulation Number and Name (Product Code in Parentheses) | 21 CFR 886.4390, Ophthalmic Laser (OOE) |
| Associated Product Codes | HNO, HQC |
| Regulatory Class | II |
Page 6
510(k)# K243896 510(k) Summary: LenSx Laser System
Page 2 of 6
3. PREDICATE DEVICE [per [807.92(a)(3)]
| Predicate Device | LenSx Laser system |
|---|---|
| 510(k) Number | K173660 |
| Regulation Number and Name (Product Code in Parentheses) | 21 CFR 886.4390, Ophthalmic Laser (OOE) |
| Associated Product Codes | HNO, HQC |
| Regulatory Class | II |
4. DEVICE DESCRIPTION
The LenSx Laser system is an ophthalmic surgical laser which uses focused femtosecond laser pulses to create vapor bubbles which disrupts/separates tissue (photodisruption) within the lens capsule, crystalline lens, and the cornea. A computer-guided delivery system places the laser pulses in a pattern to produce an incision/cut.
The laser pulses are delivered through a sterile, disposable applanating lens and suction ring that contacts the cornea and fixes the eye with respect to the laser delivery system.
The interface between the laser and patient is the Patient Interface that connects to the delivery system which is docked to the patient's cornea. Two models of the Patient Interface accessory are offered for use with the LenSx Laser: the LenSx Laser Patient Interface and the LenSx Laser SoftFit Patient Interface. Both models consist of a sterile, disposable applanating lens and suction ring assembly. The LenSx Laser SoftFit Patient Interface also comes with a soft contact lens that is positioned against the external surface of the Patient Interface glass. For cataract procedures, the LenSx Laser SoftFit Patient Interface is used. The LenSx Laser Patient Interface is used for corneal, flap, tunnel, and pocket incisions. Refer to the Instructions for Use supplied with the LenSx Laser Patient Interface for preparation and application.
The LenSx Laser system is for prescription use and should only be operated by a trained physician. The LenSx Laser system is intended to be used within a clinic(s)/hospital(s)/surgical practice network.
5. INDICATIONS FOR USE
Proposed LenSx Laser system Indications for Use:
- In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate), anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery.
Page 7
510(k)# K243896 510(k) Summary: LenSx Laser System
Page 3 of 6
-
In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate) during Implantable Collamer Lens (ICL) surgery.
-
In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
-
In the creation of corneal pockets for placement/insertion of a corneal inlay device; and for creation of corneal tunnels for the placement of corneal rings.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS TO PREDICATE
| CHARACTERISTIC | PREDICATE DEVICELENSX LASER SYSTEM | SUBJECT DEVICELENSX LASER SYSTEM |
|---|---|---|
| Administrative | ||
| 510(k) | K173660 | K243896 |
| Regulation Number | 21 CFR 886.4390 | 21 CFR 886.4390 |
| Regulatory Class | Class II | Class II |
| Product Code | OOE; HNO; HQC | OOE; HNO; HQC |
| Intended Use (Summarized) | Intended for use in cataract surgery and for the creation of corneal flaps, corneal tunnels and corneal pockets. | Same(Intended for creation of corneal cuts/incisions, pockets, tunnels, and flaps, and for anterior capsulotomy and phacofragmentation). |
| Indications for Use | The LenSx Laser system is indicated for use:• In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate), anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery.• In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.• In the creation of corneal pockets for placement/insertion of a corneal inlay device; and for creation of corneal tunnels for the placement of corneal rings. | The LenSx Laser system is indicated for use:• In the creation of corneal cuts/incisions (single-plane, multi-plane, and arcuate), anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery.• In the creation of corneal cuts/incisions(single-plane, multi-plane, and arcuate) during Implantable Collamer Lens (ICL) surgery.• In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.• In the creation of corneal pockets for placement/insertion of a corneal inlay device; and for creation of corneal tunnels for the placement of corneal rings. |
Page 8
510(k)# K243896 510(k) Summary: LenSx Laser System
Page 4 of 6
| CHARACTERISTIC | PREDICATE DEVICELENSX LASER SYSTEM | SUBJECT DEVICELENSX LASER SYSTEM |
|---|---|---|
| System Features | ||
| Operating Principle | Femtosecond laser photodisruption | Same |
| Mechanism of Action | Cutting and resection surfaces are created by scanned pattern of femtosecond laser micro-photodisruptions in tissue. | Same |
| Surgical Field Imaging | Video Microscope and Optical Coherence Tomography | Same |
| Suction Method | Integrated suction device | Same |
| Laser Mode of Operation | Pulsed | Same |
| Laser Gain Medium | Kb:KYW | Same |
| Laser Wavelength | 1030 nm | Same |
| Laser Pulse Duration | 600-800 fs | Same |
| Laser Pulse Repetition Rate | 50 kHz for cataract, 150 kHz for corneal flaps, pockets, and tunnels | 50 kHz for cataract and ICL, 150 kHz for corneal flaps, pockets, and tunnels |
| Maximum Pulse Energy | 15 µJ for cataract, 2.6 µJ for corneal flaps, pockets, and tunnels | Same |
| Maximum Average Power | 1 W during service 0.750 W for cataract0.390 W for corneal flaps, pockets, and tunnels | Same |
| Maximum Surgical Diameter (Clear Aperture) | 12.5 mm | Same |
| Maximum Depth | 8000 µm for cataract, 190 µm for corneal flaps, 400 µm for corneal pockets, and corneal tunnels | Same |
| OCT Optical Source | Superluminescent Diode | Same |
| Mode of Operation | Spectral Domain | Same |
| OCT Wavelength | 820-880 nm | Same |
| OCT Maximum Power | 3.0 mW | Same |
| Illumination for Video Microscope (VM) | LED-Light Emitting Diode | Same |
| VM Illumination Wavelength | 500-650 nm | Same |
| VM Illumination Maximum Power | 0.330 mW | Same |
| Accessories | LenSx Laser Patient InterfaceLenSx Laser SoftFit Patient Interface | Same |
| Software Features | ||
| Software Operating EnvironmentGUI & Instrument Host | QNX, version 6.3.2 | Same |
Page 9
510(k)# K243896 510(k) Summary: LenSx Laser System
Page 5 of 6
| CHARACTERISTIC | PREDICATE DEVICELENSX LASER SYSTEM | SUBJECT DEVICELENSX LASER SYSTEM |
|---|---|---|
| Software Version | LenSx Laser System version 2.31 | LenSx Laser System, version 2.40Software modifications to include addition of:• An embedded arcuate LaserArc nomogram calculator.• Horizontal, thick cross, and star phacofragmentation lens cut pattern options.• Capsulorhexis (lens) markers to align the toric intraocular lens orientation.• Corneal incision/cut setting for ICL procedure. |
7. SUMMARY OF STUDIES
7.1 Non-Clinical Testing
Biocompatibility
The LenSx Laser console is not intended to have patient contact. The materials used for the device console are common and widely used for ophthalmic and similar applications without reported heath concerns. Per ISO 10993-1, no further biocompatibility testing is required.
Sterilization and Shelf Life
The LenSx Laser console is provided non-sterile and is not intended to be sterilized during routine use. The system console is intended for use with sterile patient interface accessories.
Electromagnetic Compatibility (EMC)/ Wireless / Electrical Safety
Alcon assessed the EMC and electrical / mechanical safety of the LenSx Laser system according to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60601-4-2, and the final FDA guidance document "Electromagnetic Compatibility (EMC) of Medical Devices," issued June 6, 2022. The subject device met all requirements from the aforementioned standards and followed FDA recommendations where applicable from said guidance document.
Optical Radiation Safety
Alcon assessed the optical radiation safety of the LenSx Laser System and found that the retinal exposures are in compliance with limits for Group 1 devices defined in ANSI Z80.36-2021.
Software
Software verification and validation testing were conducted for the LenSx Laser system and met all requirements. In addition, documentation was provided as recommended by FDA
Page 10
510(k)# K243896 510(k) Summary: LenSx Laser System
Page 6 of 6
guidance for the "Content of Premarket Submissions for Software Device Software Functions," issued on June 14, 2023. The software was found to fit in the category of products that would require Enhanced Documentation Level because the failure or latent flaw of the device software function would present a hazardous situation with a probable risk of serious injury to either a patient, user of the device or others in the environment of use prior to the implementation of the risk control measures.
Alcon also fulfilled FDA's cybersecurity recommendations for the subject device in accordance with FDA guidance, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions," dated September 2023.
Performance Testing
The LenSx Laser system successfully completed bench testing which demonstrates the system's ability to meet all intended design specifications. Features introduced with the subject device have minor technological differences and do not adversely affect the safety and effectiveness of the device. Additional performance regression and toric markings capsular bag pull tests were performed to verify that these features function as intended and meet applicable design requirements. The performance data demonstrated that the device performs as intended.
Bench testing, when coupled with software verification and validation testing presented for the subject device, provides reasonable assurance that the system remains safe and effective for its intended use and furthermore, that it is substantially equivalent to the predicate device, LenSx Laser system.
7.2 Animal/Clinical Testing
The system design, architecture, indications for use, materials, and patient interface accessories are the same for both the subject device and predicate device. Therefore, the risk assessment for the subject device did not require any animal or clinical testing as mitigation against any identified risks.
8 CONCLUSION
The modified LenSx Laser system shares the same intended use as the predicate device. The hardware and software changes between the predicate and the modified device do not raise new questions of safety and efficacy of the new device. The technological characteristics affecting clinical performance are similar to those of the predicate device previously listed. Risk profiles are equivalent between the subject device and the predicate device.
The predicate devices and the subject devices have been developed and manufactured in compliance with 21 CFR 820 and ISO 14971. Non-clinical testing noted above demonstrated that the functional requirements were met, and that the subject device is equivalent to the predicate device. Therefore, the modified LenSx Laser system is deemed substantially equivalent to the currently cleared, LenSx Laser system.
§ 886.4390 Ophthalmic laser.
(a)
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.(b)
Classification. Class II.