The ELITA™ Femtosecond Laser System is an ophthalmic femtosecond laser indicated in the creation of corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea.
The ELITA™ Femtosecond Laser System is used in conjunction with a sterile disposable Patent Interface, consisting of a pre-sterilized suction ring assembly and pre-sterilized applanation cone, intended for single-use.

Device Description

The ELITATM Femtosecond Laser System is an ophthalmic laser for corneal surgical operation. The system accurately cuts cornea tissue through a high pulse repetition rate and ultra-fast scanner to place pulses tightly next to each other, generating a continuous cutting surface. The system is controlled by the graphical user interface and software real-time controls. The optical delivery system determines a 3-dimensional position in the cornea at which the laser focuses. When the laser is emitted, the energy delivered is sufficient to photo-disrupt a small volume of tissue. The process of cutting involves repetitively setting a focus point and translating the laser cutting line generated by the resonant scanner. The ELITATM Femtosecond Laser System is a CDRH Class IV laser per 21 CFR 1040.10 and 1040.11 due to intentional laser exposure of the eye.

AI/ML Overview

The provided text does not contain specific acceptance criteria, reported device performance metrics, or detailed study information for the ELITA™ Femtosecond Laser System and ELITA™ Patient Interface.

Instead, it is a 510(k) summary for a medical device seeking substantial equivalence to existing predicate devices. The core argument for acceptance is based on demonstrating that the new device is as safe and effective as the predicate devices, primarily through non-clinical testing and comparison of technological characteristics.

Therefore, I cannot populate a table of acceptance criteria and reported device performance, nor can I provide details on sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these are not discussed in the document in the context of specific quantitative criteria for this device.

Key points from the document regarding acceptance and studies:

Acceptance Criteria: The primary acceptance criterion for the 510(k) submission is demonstrating substantial equivalence to predicate devices. This is achieved by showing that the ELITA™ system has:
- Similar intended use.
- Similar indications for use.
- Similar fundamental scientific technology.
- No new harms or unacceptable risks.
Study That Proves the Device Meets Acceptance Criteria:
- Type of Study: Non-clinical studies were performed, including:
  - Bench testing.
  - Electromagnetic Compatibility (EMC) testing.
  - Software verification and validation testing.
  - Design verification and validation testing.
- Conclusion: These tests "demonstrate the system's ability to meet all intended design specifications" and provide "reasonable assurance that the system remains safe and effective for its intended use" and "is substantially equivalent to the iFS predicate device."
- Clinical Data: "Clinical Data was deemed not necessary for the ELITA™ Femtosecond Laser System and ELITA™ Patient Interface" because the device does not introduce new indications/intended use or new harms/unacceptable risks.
- Comparison to Predicates: A detailed comparison (Table 1) of the subject device (ELITA™) with a primary predicate (FEMTO LDV™ Z8) and a secondary predicate (iFS Advanced Femtosecond Laser System) was used to highlight similarities in:
  - Technological characteristics (e.g., femtosecond pulsed laser, operating principle, resection method, patient interface).
  - Indications for Use (with a note that ELITA™'s indications are "similar, more concise").
  - Laser type, wavelength, repetition rate, pulse duration, and spot size.

In summary, the document states that the device was accepted based on non-clinical testing demonstrating its performance against design specifications, and a detailed comparison showing substantial equivalence in functionality, safety, and effectiveness to legally marketed predicate devices, negating the need for clinical studies. Specific quantitative acceptance criteria or detailed results of these non-clinical tests are not provided in this 510(k) summary.

Summary

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April 14, 2023

Johnson & Johnson Surgical Vision, Inc. Amanda Houston Senior Regulatory Affairs Project Lead 31 Technology Drive Irvine, CA 92618

Re: K223566

Trade/Device Name: ELITA™ Femtosecond Laser System, ELITA™ Patient Interface Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: OOE Dated: March 14, 2023 Received: March 15, 2023

Dear Amanda Houston:

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/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.

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.

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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 devicerelated adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-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-device-advice-comprehensive-regulatoryassistance/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,

J Angelo Green -S

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for Tieuvi Nguyen, Ph.D., 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

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Indications for Use

510(k) Number (if known) K223566

Device Name

ELITA™ Femtosecond Laser System, ELITA™ Patient Interface

Indications for Use (Describe)

The ELITA™ Femtosecond Laser System is used in conjunction with a sterile disposable Patent Interface, consisting of a pre-sterilized suction ring assembly and pre-sterilized applanation cone, intended for single-use.

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)

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510(k) SUMMARY

The following 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92:

510(k) Summary:	K223566
[807.92(a)(1)] Submitter Information
Sponsor/Submitter:	AMO Manufacturing USA, LLC510 Cottonwood DriveMilpitas, CA 95035 USAPhone 408-273-5166Fax:408 273-5966
Contact Person:	Amanda HoustonSenior RA Program LeadEmail: ahousto1@its.jnj.comPhone: 562-774-8122
Date Summary Prepared:	April 6, 2023
[807.92(a)(2)] Name of Device
Device Trade Name:	ELITA™ Femtosecond Laser System, ELITA™ Patient Interface
Common Name:	Ophthalmic laser
Device Classification:	Class II
Regulation Number:	21 CFR 886.4390
Classification Name:	Ophthalmic Laser
Product Code:	OOE
[807.92(a)(3)] Legally Marketed Devices
Primary Predicate:Secondary Predicate:	Femto LDV Z8 Femtosecond Surgical Laser - K213559, ClearedApril 21, 2022 (specific to Regulation # 886.4390)iFS Advanced Femtosecond Laser System - K141852; clearedJanuary 16, 2015 (specific to intended use and technology)
Device Description:	The ELITATM Femtosecond Laser System is an ophthalmic laserfor corneal surgical operation. The system accurately cuts corneatissue through a high pulse repetition rate and ultra-fast scanner toplace pulses tightly next to each other, generating a continuouscutting surface. The system is controlled by the graphical userinterface and software real-time controls. The optical deliverysystem determines a 3-dimensional position in the cornea at whichthe laser focuses. When the laser is emitted, the energy delivered issufficient to photo-disrupt a small volume of tissue. The process ofcutting involves repetitively setting a focus point and translating thelaser cutting line generated by the resonant scanner.The ELITATM Femtosecond Laser System is a CDRH Class IVlaser per 21 CFR 1040.10 and 1040.11 due to intentional laserexposure of the eye.
	[807.92(a)(5)] Intended Use
Indications for Use:	The ELITATM Femtosecond Laser System is an ophthalmicfemtosecond laser indicated in the creation of corneal flap in patientsundergoing LASIK surgery or other surgery or treatment requiringinitial lamellar resection of the cornea.The ELITATM Femtosecond Laser System is used in conjunctionwith a sterile disposable ELITATM Patient Interface, consisting of apre-sterilized suction ring assembly and pre-sterilized applanationcone, intended for single-use.
Difference inIndications fromPredicate Device	The ELITATM Femtosecond Laser System maintains a similar,more concise Indications for Use statement as that of the FEMTOLDVTM and iFS Systems. This reduction does not impact theintended use, and the main indication (corneal lamellar resectionand flap creation) remains the same. There are no newindications/intended use introduced with the ELITATMFemtosecond Laser System and ELITATM Patient Interface.Therefore, the Indications for Use for these devices aresubstantially equivalent.
	[807.92(a)(6)] Technical Characteristics
TechnologicalCharacteristics:	The ELITATM Femtosecond Laser System and ELITATMPatient Interface (PI) share the same design principle and modeof operation with the predicate devices, in that these systems

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[807.92(a)(4)] Device Description

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deliver femtosecond pulses through a computer-controlled delivery system to produce a pattern of photo-disruption to create cuts or separation of corneal tissue, resulting in the same functionality (flap creation for LASIK surgery or other surgeries requiring lamellar resection). The ELITA™ PI characteristics are the same as the iFS PI in that the means of patient contact to the system is created via affixing a suction ring to the scleral surface of the eye prior to use, applanating the eye via vacuum, to couple the beam output to the cornea and provide a fixed reference plane for precision scanning. [807.92(b)(1)] Determination of Substantial Equivalence The ELITATM Femtosecond Laser System and ELITA™ Patient Interface successfully completed bench testing. Electromagnetic Compatibility (EMC) testing, and software and Non-Clinical design verification and validation testing. which demonstrates Performance Data: the system's ability to meet all intended design specifications. Bench testing of the iFS predicate device is directly applicable to the subject device as there are no significant changes to the subject device. Features introduced with the subject device have minor technological differences and do not adversely affect the safety and effectiveness of the device. Additional tests are performed to verify these features function as intended and meet applicable design requirements. 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 iFS predicate device. Clinical Data was deemed not necessary for the ELITA™ Femtosecond Laser System and ELITA™ Patient Interface. The performance data demonstrated that the device performs as intended. The subject device does not include any changes to the Clinical Performance indications for use or intended use of the primary or secondary Data: predicate devices. It does not introduce any new harms or unacceptable risks, and therefore does not require clinical testing to assess safety and performance or to demonstrate equivalence.

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Table 1 below provides a comparison of the predicate and subject devices and demonstrates substantial equivalence to the predicate devices for its indications for use, intended use, technological characteristics, and new features.

Attribute	Subject Device	Primary Predicate	Secondary Predicate
510(k) Number	K223566	K213559	K141852
Trade/ DeviceName	ELITATMFemtosecond LaserSystem	FEMTO LDVTM Z8Femtosecond SurgicalLaser Device	iFS AdvancedFemtosecond LaserSystem
Manufacturer	AMO ManufacturingUSA, LLC	SIE AG, SurgicalInstrument Engineering	AMO ManufacturingUSA, LLC
RegulationNumber	886.4390	Same	878.4810
RegulationName	Ophthalmic Laser	Same	General & PlasticSurgery
RegulatoryClass	Class II	Class II	Same
Product Code	OOE	Same	GEX, HNO
TechnologicalCharacteristics	Femtosecond pulsedlaser	Same	Same
OperatingPrinciple	Cutting/resection ofthe corneal tissuewithin controlledparameters throughthe use offemtosecond laserpulses which aredelivered through anapplanation devicethat fixates the eyeunder a vacuum	Same	Same
ResectionMethod	Resection created bylaser micro-photo-disruption	Same	Same
Indications forUse	The ELITATMFemtosecond LaserSystem is anophthalmicfemtosecond laserindicated in the creationof corneal flap inpatients undergoingLASIK surgery or othersurgery or treatmentrequiring initial	The FEMTO LDVTM Z8Femtosecond SurgicalLaser is an ophthalmicsurgical laser intended foruse in the creation ofcorneal incisionsindicated for use inpatients undergoingLASIK surgery, tunnelcreation for implantationof rings, pocket creation	• In patients undergoingsurgery or other treatmentrequiring initial lamellarresection of the cornea• In patients undergoingsurgery or other treatmentrequiring initial lamellarresection of the cornea tocreate tunnels forplacement of corneal ringsegments

	lamellar resection of thecornea.	corneal implants, lamellarkeratoplasty, penetratingkeratoplasty or othertreatment requiringlamellar resection of thecornea at a varying depthwith respect to the cornealsurface.	• In patients undergoingophthalmic surgery orother treatment requiringarcuate cuts/incisions inthe cornea, penetratingand/or intrastromal• In lamellar IEK andcorneal harvesting• In the creation of acorneal flap in patientsundergoing LASIKsurgery or other treatmentrequiring initial lamellarresection of the cornea• In the creation of alamellar cut/resection ofthe cornea for lamellarIEK and for the creationof a penetratingcut/incision forpenetrating IEK• In patients undergoingophthalmic surgery orother treatmentrequiring the creationof corneal channels forplacement/insertion of
Beam DeliveryDevice	Zoom lens controls thedepth of resectionMotorized gantrypositioningElectrical gantry motorslock the position of thedelivery assemblyMagnified video imageprovides a view of thesurgical fieldContact light andmaximum applanationlight; light thatindicates increasedapplanation contactpressure within theacceptable range.Cone illumination	None listed	Same as Subject Device
	Focusing objectivefocuses the beam intothe resection planeMotorized mirrors andfocusing objective scanthe laser beam throughthe fixed objective tocreate an X-Y resectionplane
Laser Type	Mode locked, diodepumped, Ytterbium-doped fiber laser	Solid state modelocked, diode pumped	Mode-locked, diode-pumped Nd:glassoscillator with a diode-pumped regenerativeamplifier
Treatment LaserWavelength(nm)	1040 nm	1020-1060nm	1053 nm
Output Power,Max	2.0 W	None listed	0.400 W
Pulse EnergyRange	45-90 nJ	None listed	300-2000 nJ
Maximum PulseEnergy (µJ)	0.2 µJ	< 6 µJ	2.5 µJ
Repetition Rate(MHz)	10 MHz	< 10 MHz with ±10%tolerance	0.15 MHz
Pulse Duration(fs)	100-200 fs	200-500 fs	600-800 fs
Spot size	< 2 µm	< 2 µm	< 3 µm
System controls	FPGA andMicroprocessors, withGraphical UserInterface	None listed	Microprocessor withGraphical User Interface
Patient Interface
Patient ContactInterface	Suction-ring typeinterface device	Same	Same
Patient InterfaceUsage	Single Use	Same	Same
Patient ContactPortion of theDevice	Contact Lens - FusedSilicaSuction Ring – TPEVersaflex	None listed	Contact Lens - Same asSubject DeviceSuction Ring - C - Flex
SterilizationMethod ofDisposable	Radiation (Gamma)	EO	Same as Subject Device

Table 1: Substantial Equivalence Table

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Source ofVacuum	Automatic	None listed	Manual
OperatingSystem	Windows 10, Linux	None listed	QNX operating systemrunning proprietary iFSsoftware
AvailableResectionPatterns	The ELITA™ Laserprovides a single five-part resection for flapcreation (using a rasterpattern with multi-layerside cut); a pocket cut isalso available formanagement of opaquebubble layer	None listed	Surgeon can choose fromthe following patterns tocreate a flap:· Spiral· Raster• Double Raster• Side Cut Only• Pocket• Flap Well· Flap + Oval• Inlay

[807.92(b)(3)] Conclusion

Conclusions from Non-Clinical and Clinical Tests: The ELITATM Femtosecond Laser System and ELITA™ Patient Interface are substantially equivalent to the currently cleared FEMTO LDV™ Femtosecond Surgical Laser (specific to regulation number) and iFS Advanced Laser System (specific to intended use and technology). The subject device and its accessory have a similar intended use, indications for use, and fundamental scientific technology compared to the predicate devices. The subject devices were determined to be substantially equivalent based on successful completion of non-clinical bench testing, Electromagnetic Compatibility (EMC) testing, software and design verification and validation testing. Based on the similarities between the subject devices and the predicates, no new risks were introduced; therefore, animal and clinical testing was not required. The successful results from the aforementioned testing were obtained using well-recognized international standards including several FDA recognized consensus standards. In addition, AMO has demonstrated through risk analysis and performance testing that the subject devices are substantially equivalent and are at least as safe and effective as the predicate devices.

Regulation Number and Section

§ 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.