VISULAS yag

K230350 · Carl Zeiss Meditec, Inc. · HQF · Sep 22, 2023 · Ophthalmic

Device Facts

• Record ID: K230350
• Device Name: VISULAS yag
• Applicant: Carl Zeiss Meditec, Inc.
• Product Code: HQF · Ophthalmic
• Decision Date: Sep 22, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

VISULAS yag is intended for use in photodisrupting ocular tissue in the treatment of diseases of the eye, including Posterior capsulotomy, Iridotomy and Posterior Membranectomy.

Device Story

VISULAS yag is a Q-switched, flashlamp-pumped Nd:YAG ophthalmic laser system. It delivers near-infrared (1064 nm) laser pulses to photodisrupt ocular tissue. The device consists of a laser source, slit lamp, graphical user interface, control panel, and footswitch. It is operated by a physician in a clinical setting. The physician uses the slit lamp and aiming beam to target ocular tissue; the laser delivers pulses (< 4 ns duration) to perform capsulotomy, iridotomy, or membranectomy. The device provides adjustable energy levels and focus shift capabilities to assist the physician in precise tissue disruption. By enabling non-invasive ocular surgery, the device benefits patients by treating specific eye conditions with controlled laser energy.

Clinical Evidence

Bench testing only. Performance evaluation included functional and system-level testing, biocompatibility testing, software verification and validation (per IEC 62304), and EMC/electrical safety testing. Results demonstrated that the device meets all defined specifications and is equivalent to the predicate device.

Technological Characteristics

Q-switched Nd:YAG laser; 1064 nm wavelength; < 4 ns pulse duration; 6.5 µm focus diameter; 9-45 mJ energy range; 14° convergence angle. User interface includes GUI, TouchControl panel, and footswitch. Integrated LED illumination. Complies with IEC 60825-1 (Laser Class 4) and ISO 15004-2 (Group 2).

Indications for Use

Indicated for adults requiring photodisruption of ocular tissue for the treatment of posterior capsulotomy, iridotomy, 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

• Ellex YAG Laser (Ultra Q, Ultra Q Reflex) (K212630)

Reference Devices

• VISULAS YAG III (K042139)

Submission Summary (Full Text)

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September 22, 2023

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

Re: K230350

Trade/Device Name: VISULAS yag Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF Dated: August 16, 2023 Received: August 16, 2023

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 (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. 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/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 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-device-reportingmdr-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/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-regulatoryassistance/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,

Bennett Digitally signed by Bennett N. ﮯ Walker -S Date: 2023.09.22 Walker -S 10:23:07 -04'00'L

for Claudine Krawczyk Acting 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) K230350

Device Name VISULAS yag

Indications for Use (Describe)

VISULAS yag is intended for use in photodisrupting ocular tissue in the treatment of diseases of the eye, including Posterior capsulotomy, Iridotomy and Posterior Membranectomy.

This device is for Prescription Use (Rx) only.

| Type of Use (Select one or both, as applicable) | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| <table><tr><td><div> <span style="font-size: 10pt;"> </span> </div></td></tr><tr><td><div> <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div></td></tr><tr><td><div> <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div></td></tr></table> | <div> <span style="font-size: 10pt;"> </span> </div> | <div> <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |
| <div> <span style="font-size: 10pt;"> </span> </div> | | | |
| <div> <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | | | |
| <div> <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | | | |

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In accordance with 21 CFR 807.92 the 510(k) Summary for the VISULAS yag is provided below.

#### 1. SUBMITTER

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

Date Prepared: September 22, 2023

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#### 2. SUBJECT DEVICE

| Device Trade Name: | VISULAS yag |
|--------------------|---------------------------------|
| Classification: | 21CFR886.4390 laser, Ophthalmic |
| Regulatory Class: | II |
| Product Code: | HQF |

#### 3. PREDICATE DEVICE

| Predicate Device: | Ellex YAG Laser (Ultra Q, Ultra O Reflex) (K212630) |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification: | 21CFR886.4390 Ophthalmic Laser |
| Regulatory Class: | ﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ |
| Product Code: | HOF |

#### 4. DEVICE DESCRIPTION

VISULAS yag uses a Q-switched, flashlamp-pumped solid-state laser for photodisruption treatments of diseases of the eye, including posterior capsulotomy, iridotomy and membranectomy. Laser radiation is generated by means of a neodymium-doped yttrium aluminum garnet (Nd:YAG) gain medium inside the laser source. The emitted laser radiation with a near-infrared wavelength of \ = 1064 nm has a pulse duration of < 4 ns (full-width half-maximum; FWHM) and a focal diameter of 6.5 um ± 20%. The maximum energy output per pulse is 9 to 13 mJ in single-burst mode.

#### INDICATIONS FOR USE .

VISULAS yag is intended for use in photodisrupting ocular tissue in the treatment of diseases of the eye, including Posterior capsulotomy, Iridotomy and Posterior Membranectomy.

This device is for Prescription Use (Rx) only.

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#### SUBSTANTIAL EQUIVALENCE TO PRIMARY PREDICATE 6.

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

| Device | Subject Device | Primary Predicate Device<br>(K212630) | Equivalency<br>Analysis |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Indications<br>for Use | VISULAS yag is intended for use in<br>photodisrupting ocular tissues in the<br>treatment of diseases of the eye,<br>including:<br>• Posterior capsulotomy<br>• Iridotomy<br>• Posterior Membranectomy | In the YAG mode (Ultra Q, Ultra Q<br>Reflex):<br>• Iridotomy and iridectomy<br>• Posterior capsulotomy<br>• Posterior membranectomy | The indication of<br>VISULAS yag is<br>equivalent to that<br>of the reference<br>device. |

## Table 2. Subject to Primary Reference Device Comparison Table – Indications for Use

| Device | Subject Device | Primary Reference Device<br>(K042139) | Equivalency<br>Analysis |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Indications<br>for Use | VISULAS yag is intended for use in<br>photodisrupting ocular tissues in the<br>treatment of diseases of the eye,<br>including:<br>• Posterior capsulotomy<br>• Iridotomy<br>• Posterior Membranectomy | This device will be used in<br>ophthalmic applications, including<br>posterior capsulotomy and peripheral<br>iridotomy. This device is intended forhealth care workers and may only be<br>used under the supervision of a<br>physician. This device will not be<br>sold to the general public. | For posterior<br>capsulotomy and<br>iridotomy, the<br>indications for use<br>are equivalent. |

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# Table 3. Subject to Predicate Device Comparison Table – Technical Characteristics

| Attribute | Subject Device | Primary Predicate Device<br>(K212630) | Primary Reference Device<br>(K042139) | Equivalency Analysis and<br>Discussion |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | VISULAS yag | Ellex YAG Laser | VISULAS YAG III | |
| | | (Ultra Q, Ultra Q Reflex) | | |
| Manufacturer | Carl Zeiss Meditec AG | Ellex Medical Pty Ltd | Carl Zeiss Meditec AG | |
| 510(k) | K230350 | K212630 | K042139 | |
| Classification Product<br>Code | HQF | HQF | GEX | Substantially Equivalent.<br>Though the reference<br>device was cleared under<br>product code 'GEX' in<br>regulation 21 CFR<br>878.4810, current devices<br>with these indications for<br>use and technological<br>characteristics are classified<br>under product code 'HQF'<br>("Laser, Ophthalmic") in<br>regulation 21 CFR 886.4390<br>("Ophthalmic laser"). |
| Regulation # | 21CFR886.4390 | 21CFR886.4390 | 21CFR878.4810 | Substantially Equivalent. |
| | Ophthalmic Laser | Ophthalmic Laser | Laser surgical instrument for<br>use in general and plastic<br>surgery and in dermatology | |
| Application | Ophthalmic surgery | Ophthalmic surgery | Ophthalmic surgery | Substantially Equivalent. |
| Combination Device | No | No | No | Substantially Equivalent. |
| Patient Population | Adults | No restrictions given in the<br>operator manual | Adults | Substantially Equivalent. |
| Attribute | Subject Device | Primary Predicate Device<br>(K212630) | Primary Reference Device<br>(K042139) | Equivalency Analysis and<br>Discussion |
| User Interface | Graphical user interface,<br>TouchControl panel, foot<br>switch, laser slit lamp | Remote control, console,<br>footswitch pedal, laser slit<br>lamp | Graphical user interface,<br>control, foot switch, laser slit<br>lamp | Substantially Equivalent. |
| Optic Principle | Q-switched Nd:YAG laser | Q-switched Nd:YAG laser | Q-switched Nd:YAG laser | Substantially Equivalent. |
| Wavelength of<br>Treatment Beam | 1064 nm | 1064 nm | 1064 nm | Substantially Equivalent. |
| Laser Class in<br>Accordance with IEC<br>60825-1 | 4 | 3B | 4 | Substantially Equivalent.<br>The subject device utilizes<br>standard IEC 60825-1<br>which contains safety<br>requirements that shall be<br>followed to allow equally<br>safe usage of the lasers in<br>humans. |
| Light Hazard<br>Classification<br>According to ISO<br>15004-2 | Group 2 | Group 2 | Group 2 | Substantially Equivalent. |
| Mode of Laser Beam | Super Gaussian | Not specified in the operator<br>manual | Super Gaussian | Substantially Equivalent. |
| Pulse Length | < 4 ns | < 4 ns | < 4 ns (typically 2 ns to 3 ns) | Substantially Equivalent. |
| Pulse Mode 1 (Single<br>Pulse) | 9.0 mJ to 13.0 mJ, at max.<br>2.5 Hz | 0.3 mJ to 10.0 mJ single pulse.<br>Max. 3.0 Hz | 9.0 mJ to 13.0 mJ, 2.5 Hz<br>(5 shots/ 2s) | Substantially Equivalent. |
| Pulse Mode 2 (Double<br>Pulse) | 18.0 mJ to 28.0 mJ, at max.<br>1 Hz (burst frequency<br>33 kHz) | Not specified. Max. 1.8 Hz | 18.0 mJ to 28.0 mJ, 1 Hz<br>(1 shots/ 1s) (burst frequency<br>33 kHz) | Substantially Equivalent. |
| Attribute | Subject Device | Primary Predicate Device<br>(K212630) | Primary Reference Device<br>(K042139) | Equivalency Analysis and<br>Discussion |
| Pulse Mode 3 (Triple<br>Pulse) | 29.0 mJ to 45.0 mJ, at max.<br>1 Hz (2 shots/ 2s) (burst<br>frequency 33 kHz) | Not specified. Max. 1.6 Hz | 29.0 mJ to 45.0 mJ, 0.5 Hz<br>(1 shots/ 2s) (burst frequency 33<br>kHz) | Substantially Equivalent. |
| Energy Attenuation | 2/4/6/8/10/12/14/16/20/24/<br>28/32/36/40/42/48/56/60/6<br>4/70/80/100 % | Not specified. | 2/4/6/8/10/12/14/16/20/24/<br>28/32/36/40/42/48/56/60/6<br>4/70/80/100 % | Substantially Equivalent. |
| Applied Energy | Resulting from pulse mode<br>and attenuation:<br>0.18 mJ – 13.0 mJ single<br>pulse in 22 steps.<br>Maximum energy that can<br>be delivered during clinical<br>use is 45 mJ. | 0.3 mJ to 10.0 mJ single pulse.<br>Continuously variable.<br>Maximum energy that can be<br>selected during clinical use is<br>30 mJ. | Average from the last five<br>shots, continuously updated<br>during the session.<br>Maximum energy output is<br>10 mJ. | Substantially Equivalent. |
| Focus diameter | 6.5 µm ± 20% | 8 µm (Full Width Half<br>Maximum) | 10 µm in air | Substantially Equivalent.<br>The subject device has<br>refined the measuring<br>method of the predicate<br>device. The focus diameter<br>for both lasers are identical. |
| Angle of Exit Aperture<br>(Convergence) | 14° (round angle) | 16° (full cone angle) | 16° (round angle) | Substantially Equivalent.<br>The subject device has<br>refined the measuring<br>method of the predicate |
| Attribute | Subject Device | Primary Predicate Device<br>(K212630) | Primary Reference Device<br>(K042139) | Equivalency Analysis and<br>Discussion |
| Aiming Beam | Diode<br>Wavelength: 660 nm to 680 nm<br>Power: max. 150 µW at the<br>cornea (Class I in<br>accordance with IEC<br>60825-1)<br>Four-point aiming beam<br>which is switchable to 2-<br>point aiming beam | Laser diode-pumped<br>Wavelength:<br>Ultra Q: 635 nm<br>Ultra Q Reflex: 635 nm or 515 nm<br>Class II in accordance to IEC<br>60825-1<br>2-point aiming beam | Diode<br>Wavelength: 660 nm to 680 nm<br>Power: max. 150 µW at the<br>cornea (Class I in accordance<br>with IEC 60825-1)<br>Four-point aiming beam | device. The convergence<br>angles are identical.<br>Substantially Equivalent. |
| Nominal Ocular Hazard<br>Distance (NOHD) | 4 m | 6.1 m | 2 m | The NOHD differs due to<br>differences in the design.<br>This difference does not<br>impact the safety or<br>performance of the subject<br>device. |
| Rated Voltage;<br>Frequency | 100 V to 240 V (±10 %);<br>50 /60 Hz | 100 V to 240 VAC; 50/60 Hz | 100 V to 240 V ±10 %;<br>50 Hz/60 Hz | Substantially Equivalent. |
| Focus Shift between<br>Aiming Beam and<br>Therapy Beam | 0/150/225/300 µm anterior<br>and posterior adjustable<br>Tolerance: ±25 µm | Ultra Q: Posterior only,<br>continuously variable with<br>detents at 100, 250 and 350 µm<br>Ultra Q Reflex: Anterior (A) &<br>posterior (P), continuously<br>variable with detents at 0, 100,<br>200, 300, 400 and 500 µm | 0/150 µm anterior and posterior<br>adjustable<br>Tolerance: ±25 µm | Substantially Equivalent. |
| Illumination | LED<br>5.6 V, 2 W | 12 V pre-centered halogen | Halogen lamp<br>12 V, 30 W | Different. |
| Attribute | Subject Device | Primary Predicate Device<br>(K212630) | Primary Reference Device<br>(K042139) | Equivalency Analysis and<br>Discussion |
| | Brightness continuously<br>adjustable | | Brightness continuously<br>adjustable | |
| Illumination<br>Orientation | Non-coaxial | Ultra Q: non-<br>coaxial Ultra<br>Q Reflex:<br>coaxial | Non-coaxial | Substantially Equivalent. |
| Illumination Angle | 0°/±45°/90° | 180° at horizontal plane<br>(90° for right / left) | 0°/±45°/90° | Substantially Equivalent. |
| Slit Width | 0 mm to 14 mm<br>(continuously adjustable) | 0 - 12 mm | 0 mm to 14 mm<br>(continuously adjustable) | Substantially Equivalent. |
| Slit Height | 1/3/5/9/14 mm | 0.5, 5.0, 8.0 & 12.0 or 0.5, 3.0,<br>8.0 & 12.0 mm | 1/3/5/9/14 mm | Substantially Equivalent. |
| Magnification | 8x/12x/20x | Ultra Q:<br>Standard: 10×, 16×, 28×<br>Accessory: 6×, 10×, 16×, 28×,<br>45×<br>Ultra Q Reflex<br>Standard: 10×, 16×, 25×<br>Accessory: 6×, 10×, 16×, 28×,<br>45× | 5x/8x/12x/20x/32x | Substantially Equivalent. |

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#### 7. SUMMARY OF STUDIES

### Non-Clinical Performance Testing

Non-clinical system testing provided an evaluation of the performance 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, VISULAS yag, and the predicate device, VISULAS YAG III.

VISULAS yag is not intended for sterilization and no shelf life is specified for VISULAS yag. Therefore, no testing was conducted on VISULAS yag concerning sterilization and shelf life.

Biocompatibility testing was performed on the appropriate components of the subject device. The testing performed aligns with current recognized standards and meets or exceeds testing performed on VISULAS YAG III. Biocompatibility testing demonstrated equivalency between VISULAS yag III.

Software verification and validation testing were conducted, and documentation was provided as recommended in accordance with IEC 62304. There have been no changes in level of concern or software architecture. All testing passed.

EMC and electrical safety are used in comparable standards to the predicate device and the relevant product standards given by the product indication and performance. Electrical safety and EMC testing were performed based on the ILAC-Scheme to include all national deviations for VISULAS yag. All testing passed.

No additional safety or performance concerns have been raised during development or device testing.

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#### 8. CONCLUSION

The indications for use are identical to the indications for use of the predicate device; and therefore, are deemed to be substantially equivalent.

The technological characteristics and risk profile of the subject device are equivalent to the predicate device; and therefore, are deemed to be substantially equivalent.

Testing methods are equivalent to those of the predicate device; and therefore, are deemed to be substantially equivalent.

Therefore, the subject device meets the requirements for substantial equivalence as compared to the proposed predicate device.