VISULAS combi

K233911 · Carl Zeiss Meditec, AG · HQF · Sep 6, 2024 · Ophthalmic

Device Facts

• Record ID: K233911
• Device Name: VISULAS combi
• Applicant: Carl Zeiss Meditec, AG
• Product Code: HQF · Ophthalmic
• Decision Date: Sep 6, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

VISULAS combi is intended for use in photocoagulating and photodisrupting ocular tissues in the treatment of diseases of the eye, including: • Photocoagulation of the retina • Trabeculoplasty • Iridotomy • Posterior capsulotomy • Posterior membranectomy

Device Story

VISULAS combi is an ophthalmic laser system for photocoagulation (532 nm) and photodisruption (1064 nm) of ocular tissues. System components include laser console, touch control panel, laser slit lamp or indirect ophthalmoscope, foot switch, and table. Operates in single-spot, multi-spot, and YAG disruption modes. Used in clinical settings by physicians. Photocoagulation uses continuous wave thermal energy absorption; photodisruption uses laser-induced plasma formation to create mechanical shock waves for tissue incision. Output is controlled laser energy delivered to ocular structures. Benefits include precise treatment of retinal and anterior segment pathologies. Physician visualizes target via slit lamp and controls parameters via console to affect clinical decision-making and therapeutic outcomes.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, biocompatibility testing (ISO 10993-1), and software verification/validation. System testing confirmed compliance with electrical/laser safety standards (ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60825-1, etc.).

Technological Characteristics

Solid-state frequency-doubled laser (532 nm) and Q-switched Nd:YAG laser (1064 nm). Features include LED-illuminated slit lamp, micromanipulator, and foot switch. Connectivity via laser console. Software-controlled treatment modes (VERTE, VITE, YAG licenses). Complies with IEC 60601-1, IEC 60825-1, and ISO 15004-2.

Indications for Use

Indicated for patients requiring photocoagulation or photodisruption of ocular tissues for eye diseases, including retinal photocoagulation, trabeculoplasty, iridotomy, posterior capsulotomy, and posterior membranectomy.

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

• VISULAS green (K232051)
• VISULAS yag (K230350)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 6, 2024

Carl Zeiss Meditec AG Tanesha Bland Sr. Regulatory Affairs Specialist Carl Zeiss Meditec, Inc. 5300 Central Parkway Dublin, California 94568

Re: K233911

Trade/Device Name: VISULAS combi Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF Dated: August 2, 2024 Received: August 5, 2024

Dear Tanesha Bland:

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.

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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 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-reportingcombination-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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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

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### Indications for Use

510(k) Number (if known) K233911

Device Name VISULAS combi

Indications for Use (Describe)

VISULAS combi is intended for use in photocoagulating and photodisrupting ocular tissues in the treatment of diseases of the eye, including:

• Photocoagulation of the retina

- Trabeculoplasty
- · Iridotomy
- · Posterior capsulotomy

· Posterior membranectomy

This device is Prescription Use (Rx) only.

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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Image /page/4/Picture/0 description: The image shows the word "ZEISS" in white text on a blue background. The text is in a bold, sans-serif font. The blue background is a solid color, and the word "ZEISS" is centered on the background. The bottom of the blue background is curved.

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92), the 510(k) Summary for VISULAS combi is provided below.

#### SUBMITTER 1.

| Applicant: | Carl Zeiss Meditec AG<br>Goeschwitzer Strasse 51-52<br>07745 Jena<br>Germany |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Dr. Ling Ren<br>Regulatory Affairs Manager<br>Carl Zeiss Meditec AG<br>Goeschwitzer Strasse 51-52 07745 Jena, Germany<br>Phone: [phone]<br>E-mail: [e-mail] (preferred) |
| Primary Correspondent | Tanesha Bland<br>Sr. Regulatory Affairs Specialist<br>Carl Zeiss Meditec, Inc.<br>5300 Central Parkway Dublin, CA 94568<br>Phone: [phone] Fax: [phone]<br>E-mail: [e-mail] (preferred) |
| Date Prepared: | August 30, 2024 |

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#### SUBJECT DEVICE 2.

| Device Trade Name: | VISULAS combi |
|--------------------|---------------------------------|
| 510(k) number: | K233911 |
| Classification: | 21CFR886.4390 laser, Ophthalmic |
| Regulatory Class: | II |
| Product Code: | HQF |

#### PREDICATE DEVICE 3.

#### Table 1. Primary Predicate Device- VISULAS green

| Predicate Device: | VISULAS green |
|-------------------|---------------------------------|
| 510(k) Number: | K232051 |
| Classification: | 21CFR886.4390 Laser, Ophthalmic |
| Regulatory Class: | II |
| Product Code: | HQF |

| Table 2. Secondary Predicate Device- VISULAS yag | | |
|--------------------------------------------------|--|--|
| | | |

| Predicate Device: | VISULAS yag |
|-------------------|---------------------------------|
| 510(k) Number: | K230350 |
| Classification: | 21CFR886.4390 Laser, Ophthalmic |
| Regulatory Class: | II |
| Product Code: | HQF |

#### DEVICE DESCRIPTION 4.

VISULAS combi is an ophthalmic laser used for standard photocoagulation treatments of ocular tissue with 532 nm wavelength and standard photodisruption treatments of ocular tissues at a wavelength of 1064 mm. VISULAS combi is operated in the following treatment modes:

- single-spot mode (software license VERTE) -
- multi-spot mode (software license VITE)
- YAG disruption mode (software license YAG). -

VISULAS combi consists of a laser console, touch control panel, optional laser light applicators such as laser slit lamp or laser indirect ophthalmoscope, foot switch and instrument table. The device can also be used with various accessories, such as SL Imaging Solution, contact lenses or Applanation Tonometer.

#### ನ. INDICATIONS FOR USE

VISULAS combi is intended for use in photocoagulating and photodisrupting ocular tissues in the treatment of diseases of the eye, including

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Image /page/6/Picture/0 description: The image shows the word "ZEISS" in white letters against a blue background. The word is in a bold, sans-serif font. The blue background is a solid color, and the white letters stand out clearly against it. The logo is simple and modern.

- . Photocoagulation of the retina
- Trabeculoplasty
- Iridotomy •
- Posterior capsulotomy •
- Posterior membranectomy .

This device is Prescription Use (Rx) only.

#### 6. SUBSTANTIAL EQUIVALENCE TO PRIMARY PREDICATE

#### Table 1. Subject to Primary Predicate Device Comparison Table – Indications for Use

| | VISULAS combi | VISULAS green |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K number | Subject Device | K232051 |
| Legal manufacturer | Carl Zeiss Meditec AG | Carl Zeiss Meditec AG |
| Indications for Use Statement | VISULAS combi is intended for use<br>in photocoagulating and<br>photodisrupting ocular tissues in the<br>treatment of diseases of the eye,<br>including<br>• Photocoagulation of the retina<br>• Trabeculoplasty<br>• Iridotomy<br>• Posterior capsulotomy<br>• Posterior membranectomy | VISULAS green is intended for use<br>in photocoagulating ocular tissues in<br>the treatment of diseases of the eye,<br>including<br>• Photocoagulation of the retina<br>• Trabeculoplasty<br>• Iridotomy |
| | General Laser Specifications | |
| Laser type | solid state laser, frequency-doubled | solid state laser, frequency-doubled |
| Wavelength | 532 nm | 532 nm |
| Power (cw laser) | 50 to 1500 mW | 50 to 1500 mW |
| Length of pulse | 10 - 2500 ms and cw | 10 - 2500 ms and cw |
| Repeat mode | yes | yes |
| Laser spot size settings | 50 μm to 1000 μm | 50 μm to 1000 μm |
| Aiming beam | 620 - 650 nm | 620 - 650 nm |
| Types of laser applicators | LSL, laser endoprobes, LIO | LSL, laser endoprobes, LIO |
| Multi-spot treatment mode | yes | yes |
| Increments of power | 50-200 mW (10 mW steps), 200-<br>500 mW (20 mW steps), 500-1500<br>mW (50 mW steps) | 50-200 mW (10 mW steps), 200-<br>500 mW (20 mW steps), 500-1500<br>mW (50 mW steps) |
| Laser spot size setting | Continuously adjustable from<br>50 μm to 1000 μm | Continuously adjustable from<br>50 μm to 1000 μm |
| | Conditions of Use | |
| Site in the body | eye | eye |
| Principle of operation | Photocoagulation of ocular tissue | Photocoagulation of ocular tissue |

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# Table 2. Subject to Primary Predicate Device Comparison Table - Laser Slit Lamp

The Laser Slit Lamp (LSL) is an optional component of the VISULAS laser.

| | LSL green combi | LSL green comfort |
|---------------------|---------------------------------------------------------|----------------------------------------------------------|
| K number | Component of subject device<br>VISULAS combi | Component of predicate device<br>VISULAS green (K232051) |
| Legal manufacturer | Carl Zeiss Meditec AG | Carl Zeiss Meditec AG |
| Design | | |
| Slit lamp type | ZEISS type | ZEISS type |
| Tube system | Parallel or convergent | Parallel or convergent |
| Power supply | Via laser console | Via laser console |
| Specifications | | |
| Slit width | 0 mm to 14 mm (continuously) | 0 mm to 14 mm (continuously) |
| Slit length | 1/3/5/9/14 mm | 1/3/5/9/14 mm |
| Slit image rotation | 0°, ±45°, 90° | 0°, ±45°, 90° |
| Magnification | 5 magnifications, in steps of 5x, 8x,<br>12x, 20x, 32x | 5 magnifications, in steps of 5x, 8x,<br>12x, 20x, 32x |
| Light source | LED illumination, continuously<br>adjustable brightness | LED illumination, continuously<br>adjustable brightness |
| Micromanipulator | yes | yes |

The subject device VISULAS combi and the primary predicate device VISULAS green are both intended as ophthalmic lasers for photocoagulation treatments, the indications for use are within the same intended use as the predicate device and do not raise different questions of safety and effectiveness.

The subject device VISULAS combi and the primary predicate laser system share the same fundamental parameters and the same fundamental principle of operation:

Photocoagulation: Continuous wave operation in which thermal energy created by the absorption of the laser energy by the ocular tissue is causing coagulation.

For photocoagulation treatments, the subject device VISULAS combi is substantially equivalent to the primary predicate laser system presented in the 510(k) premarket notification in terms of indications for use and technological characteristics. Differences between subject devices do not raise any new issues of safety or effectiveness.

| | | | Table 3. Subject to Secondary Predicate Device Comparison Table - Indications for Use | |
|--|--|--|---------------------------------------------------------------------------------------|--|
| | | | | |

| | VISULAS combi | VISULAS yag |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K number | Subject Device | K230350 |
| Legal manufacturer | Carl Zeiss Meditec AG | Carl Zeiss Meditec AG |
| Indications for Use Statement | VISULAS combi is intended for use<br>in photocoagulating and<br>photodisrupting ocular tissues in the<br>treatment of diseases of the eye,<br>including<br>Photocoagulation of the retina Trabeculoplasty | VISULAS yag is intended for use in<br>photodisrupting ocular tissues in the<br>treatment of diseases of the eye,<br>including Posterior capsulotomy Iridotomy Posterior membranectomy |

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Image /page/8/Picture/0 description: The image shows the ZEISS logo. The logo consists of the word "ZEISS" in a bold, sans-serif font. The text is white and is set against a dark blue background.

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| | Iridotomy Posterior capsulotomy Posterior membranectomy | |
|---------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------------------------------------------|
| General Laser Specifications | | |
| Optic principle | Q-switched Nd:YAG laser | Q-switched Nd:YAG laser |
| Wavelength of treatment beam | 1064 nm | 1064 nm |
| Pulse duration | < 4 ns | < 4 ns |
| Laser class in accordance with<br>IEC 60825-1 | 4 | 4 |
| Light hazard classification according<br>to ISO 15004-2 | Group 2 | Group 2 |
| Pulse Mode 1 (Single Pulse) | 9.0 mJ to 13.0 mJ, at max. 2.5 Hz | 9.0 mJ to 13.0 mJ, at max. 2.5 Hz |
| Pulse Mode 2 (Double Pulse) | 18.0 mJ to 28.0 mJ, at max. 1 Hz<br>(burst frequency 33 kHz) | 18.0 mJ to 28.0 mJ, at max. 1 Hz<br>(burst frequency 33 kHz) |
| Pulse Mode 3 (Triple Pulse) | 29.0 mJ to 45.0 mJ, at max. 1 Hz (2<br>shots/ 2s) (burst frequency 33 kHz) | 29.0 mJ to 45.0 mJ, at max. 1 Hz (2<br>shots/ 2s) (burst frequency 33 kHz) |
| Conditions of Use | | |
| Site in the body | eye | eye |
| Principle of operation | Photodisruption of ocular tissue | Photodisruption of ocular tissue |

#### Table 4. Subject to Reference Device Comparison Table - Laser Slit Lamp

The Laser Slit Lamp (LSL) is an optional component of the VISULAS laser.

| | LSL green combi | LSL yag |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| K number | Component of subject device<br>VISULAS combi | Component of reference device<br>VISULAS yag (K230350) |
| Legal manufacturer | Carl Zeiss Meditec AG | Carl Zeiss Meditec AG |
| Design | | |
| Laser beam guidance | Free beam arrangement in the head of<br>the laser slit lamp | Free beam arrangement in the head of<br>the laser slit lamp |
| Energy attenuation | 22 levels:<br>2/4/6/8/10/12/14/16/20/24/<br>28/32/36/40/42/48/56/60/6 4/70/80/100<br>% | 22 levels:<br>2/4/6/8/10/12/14/16/20/24/<br>28/32/36/40/42/48/56/60/6 4/70/80/100<br>% |
| YAG focus diameter | 6.5 µm ± 20% in air | 6.5 µm ± 20% in air |
| YAG laser beam divergence | 14° ± 20% (round angle) | 14° ± 20% (round angle) |
| YAG aiming beam | Diode, 2-point / 4-point (switchable)<br>660 nm to 680 nm, max. 150 µm at the<br>cornea (class 1 in accordance with<br>IEC 60825-1) | Diode, 2-point / 4-point (switchable)<br>660 nm to 680 nm, max. 150 µm at the<br>cornea (class 1 in accordance with<br>IEC 60825-1) |
| Focus shift between aiming and<br>therapy beam | 0/150/225/300 µm, toggle between<br>anterior and posterior | 0/150/225/300 µm, toggle between<br>anterior and posterior |
| Nominal Ocular Hazard Distance<br>(NOHD) of YAG laser | 4 m | 4 m |

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Image /page/9/Picture/0 description: The image shows the word ZEISS in a bold, sans-serif font. The word is white and is set against a dark blue background. The logo is simple and modern, and the contrast between the white text and the blue background makes it easy to read.

The subject device VISULAS combi and the secondary predicate device VISULAS yag are both intended as ophthalmic lasers for photodisruption freatments, the indications for use are within the same intended use as the reference device and do not raise different questions of safety and effectiveness. The subject device VISULAS combi and the reference laser system share fundamental parameters and the same fundamental principle of operation:

Photodisruption: At the focus point of the laser beam pressure and temperature are very high to result in the formation of a laser-induced plasma allowing tissue photodisruption to take place. As the plasma expands, it cools down rapidly; hence, the thermal effect on adjacent tissue is very low. The mechanical stress to adjacent tissue due to the shock wave accompanying the photodisruption expansion of the plasma results in an incisional effect.

For photoisruption treatments, the subject device VISULAS combi is substantially equivalent to the secondary laser system presented in the 510(k) premarket notification in terms of indications for use and technological characteristics. Differences between subject device and reference devices do not raise any new issues of safety or effectiveness.

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Image /page/10/Picture/0 description: The image shows the ZEISS logo. The logo consists of the word "ZEISS" in a bold, sans-serif font, set against a solid blue background. Below the word, there is a curved shape, also in blue, that suggests a lens or optical element. The overall design is clean and modern, reflecting the company's focus on precision optics and technology.

#### 7. SUMMARY OF STUDIES

### Biocompatibility Testing

ZEISS conducted biocompatibility testing on patient-contacting accessories in accordance with ISO 10993-1. The evaluations addressed cytotoxicity, sensitization, aligning with the recommendations delineated in the FDA guidance document "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing within a Risk Management Process". The testing performed aligns with current recognized standards and meets or exceeds testing performed on the predicate device. Biocompatibility testing demonstrated equivalency between the subject device and the predicate device.

### Laser safety, electrical safety and electromagnetic compatibility (EMC)

VISULAS combi was evaluated against the following requirements and was found to comply with: · ANSI/AAMI ES60601-1:2005/(R) 2012

- ANSI Z80.36-2016
- · IEC 60601-1-2:2014
- · IEC 60825-1:2007
- IEC 60601-2-22:2012
- IEC 62133: 2012
- IEC 60601-4-2

# Software Verification and Validation Testing

The software of this device is considered to have an Enhanced Documentation Level. Software verification and validation testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Verification and validation of VISULAS combi demonstrated that the product works as designed.

### Bench Testing

Non-clinical system testing provided an evaluation of the system relevant to each of the system specifications. The functional and system level testing showed that the system met the defined specifications. ZEISS demonstrated non-clinical equivalency between the subject device and the predicate device.

### Animal Testing

Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.

# Clinical Data

Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device.

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#### CONCLUSION 8.

The VISULAS combi is substantially equivalent to the primary predicate device VISULAS green (K232051) and the secondary predicate device VISULA yag (K230350).

The VISULAS combi is similar in technological characteristics, performance, principles of operation, and has identical indications for use as the primary predicate device and the secondary predicate device. Any differences between the proposed device and the predicate devices do not raise any new issues.

Results of the non-clinical performance testing support a determination of substantial equivalence between the subject device and the predicate devices for the proposed intended use.

Thus, the VISULAS combi meets the requirements for substantial equivalence as compared to the predicate devices, VISULAS green (K232051) and VISULAS yag (K230350).