The VISALIS V500 and VISALIS S500 Surgical System is indicated for surgical treatment of the eye by performing irrigation /suction, phacoemulsification of the crystalline lens, anterior vitrectory and coagulation techniques using bipolar diathermy.

The VISALIS V500 is indicated for use in vitreo-retinal surgery such as retinal detachment and other pathologies of the vitreous body and the posterior segment of the human eye.

Device Description

The VISALIS V500 / VISALIS S500 Surgical System has been designed to be used in surgical theaters by qualified medical personnel (eye surgeon) for surgical methods of treatment of the anterior and posterior segment of the human eye. The equipment has been designed for the performance of irrigation, irrigation/suction, phacoemulsification of crystalline lens, anterior and posterior vitrectomy, bipolar diathermy coagulation techniques, air and silicone oil tamponade, endoocular illumination. The system is intended for use in clinics, hospitals or other human medicine institutions.

AI/ML Overview

The provided text describes a 510(k) submission for the Carl Zeiss Meditec AG VISALIS V500 / VISALIS S500 Surgical System. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing data on an AI/Algorithm-only device or an MRMC study.

Therefore, many of the requested criteria cannot be extracted from this document, as they are not relevant to a traditional 510(k) for a surgical system and its accessories demonstrating equivalence to an existing device. The document primarily details compliance with various medical device standards (e.g., safety, EMC, software, biocompatibility, sterilization) to show that the new device is as safe and effective as the predicate.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document doesn't provide specific quantitative acceptance criteria or performance metrics in a table format for the device's surgical functions (e.g., phacoemulsification efficiency, aspiration rates). Instead, it states compliance with a large number of recognized standards. The "performance data" summary lists these compliance tests, implying that meeting these standards constitutes the acceptance criteria.

Acceptance Criteria (Standards Met)	Reported Device Performance
ISO 14971:2007 (Risk Management)	Compliance demonstrated.
ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Basic safety and essential performance)	Found to be in compliance.
IEC 60601-1-2:2014 (Electromagnetic compatibility (EMC))	Found to be in compliance.
IEC 60601-2-2:2017 (High frequency surgical equipment and accessories)	Found to be in compliance.
IEC 80601-2-58:2008 (Lens removal devices and vitrectomy devices)	Found to be in compliance.
IEC 62304:2006/A1:2015 (Software lifecycle processes)	Software documented and tested; found to be in compliance.
IEC 62366-1:2015 (Usability engineering)	Compliance demonstrated.
IEC 15752:2010 (Endoilluminators and optical radiation safety)	Found to be in compliance.
ISO 10993-1:2009 (Biocompatibility - Part 1: Evaluation and testing)	Applicable accessories found to be in compliance.
ISO 10993-5:2009 (Biocompatibility - Part 5: In vitro genotoxicity tests)	Applicable accessories found to be in compliance.
ISO 10993-10:2010 (Biocompatibility - Part 10: Tests for irritation and skin sensitization)	Applicable accessories found to be in compliance.
ST72:2011/(R)2016 (Sterilization, Industrial)	Applicable accessories found to be in compliance.
ISO 17665-1:2006 (Sterilization of health care products - Moist heat)	Applicable accessories found to be in compliance.
ISO 11135:2014 (Sterilization of health care products - Ethylene oxide)	Applicable accessories found to be in compliance.
ISO 10993-7:2008-10 (Biocompatibility - Part 7: Ethylene oxide sterilization residuals)	Applicable accessories found to be in compliance.
ISO 11737-2:2009 (Sterilization of medical devices - Microbiological methods - Sterility tests)	Applicable accessories found to be in compliance.
F88/F88M-15 (Standard Test Method for Gross Leakage of Packaging by Internal Pressurization (Bubble Test))	Applicable accessories found to be in compliance.
F1929-2015 (Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration)	Applicable accessories found to be in compliance.

2. Sample size used for the test set and the data provenance:
Not applicable. This is a 510(k) for a conventional medical device, not an AI/ML algorithm that would typically have a test set of data. The "testing" refers to compliance with performance and safety standards, often done on prototype devices or components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. There is no "ground truth" derived from expert consensus in the context of this 510(k). The evaluation is against established standards and equivalence to a predicate device, not diagnostic performance of an AI.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. See point 3.

5. 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:
Not applicable. This device is a surgical system, not an AI-assisted diagnostic tool. No MRMC study or AI assistance is mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm-only device. It is a physical surgical system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The "ground truth" for this submission are the established performance and safety standards (e.g., ISO, IEC) and the functional specifications of the predicate device. The study demonstrates performance based on engineering tests and compliance, not clinical diagnostic accuracy.

8. The sample size for the training set:
Not applicable. There is no AI/ML model for which "training data" would be collected.

9. How the ground truth for the training set was established:
Not applicable. There is no AI/ML model.

Summary

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Image /page/0/Picture/0 description: The image shows 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 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.

June 15, 2020

Carl Zeiss Meditec AG Katrin Faber Regulatory Affairs Manager / MED-RAO Goeschwitzer Strasse 51-52 Jena, 07745 DE Thuringen

Re: K193376

Trade/Device Name: Visalis V500, Visalis S500 Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: Class II Product Code: HQC Dated: April 24, 2020 Received: May 6, 2020

Dear Katrin Faber:

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 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

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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-devices/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 (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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

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) K193376

Device Name VISALIS V500 / VISALIS S500

Indications for Use (Describe)

The Indication for Use is as follows:

The VISALIS V500 is indicated for use in vitreo-retinal surgery such as retinal detachment and other pathologies of the vitreous body and the posterior segment of the human eye.

ACCESSORIES:

ULITE PHACO HANDPIECE

This active re-usable device is an accessory for ZEISS phaco systems. It has been designed to emulsify and aspirate the eye lens during human eye surgery by phacoemulsification technique.

DIATHERMY PROBES

The DIATHERMY PROBES are active re-usable device is an accessory for ZEISS phaco systems. It has been designed to cauterize (stop bleeding) small vessels during human eye surgery on the anterior segment.

ENDODIATHERMY PROBES

This active single use device is an accessory of ZEISS phaco systems with posterior segment functionality. It has been designed to cauterize (stop bleeding) small vessels in the eye bulb and/or on the retina using a high frequency electrical current (generated from the equipment to which it is connected) passed through tissue from one electrode to another.

ENDOILLUMINATION PROBES

This single use device is an accessory of ZEISS phaco systems with posterior segment functionality. It has been designed to internally illuminate the eye bulb transmitting the light emitted by a xenon lamp.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/4/Picture/0 description: The image contains the word "ZEISS" in white text on a blue background. The word is written in a bold, sans-serif font. The blue background is a solid rectangle, and the word "ZEISS" is centered within the rectangle. The logo is simple and modern.

510(k) SUMMARY

(per 21 CFR §807.92)

VISALIS V500 / VISALIS S500

GENERAL INFORMATION	K193376
Manufacturer:	Carl Zeiss Meditec AG
	Goeschwitzer Strasse 51-52
	07745 Jena, Germany
	+49 7364-201606 (phone)
Contact Person:	Dr. Katrin Faber
	Senior Regulatory Affairs Manager
	Carl Zeiss Meditec AG
	Rudolf-Eber-Strasse 11
	73447 Oberkochen, Germany
	+49 7364-201606 (Phone)
	E-mail: katrin.faber@zeiss.com
Date prepared:	April 23, 2020
Classification Name:	Phacofragmentation system
Product Code and Class:	HQC - Class 2
Classification:	21 CFR 886.4670 / Panel: Ophthalmic
Common Name	Phacofragmentation/ Vitrectomy system
Trade/Proprietary Name:	VISALIS V500
	VISALIS S500
Predicate Device	ALCON CONSTELLATION ® Vision System
Predicate 510(k)	K141065

Carl Zeiss Meditec AG

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Image /page/5/Picture/0 description: The image shows the logo for Zeiss, a German manufacturer of optical systems and optoelectronics. The logo consists of the word "ZEISS" in a bold, sans-serif font. The text is white and is set against a solid blue background. The logo is simple and recognizable.

DEVICE DESCRIPTION (21 CFR §807.92(a)(4))

To perform the ophthalmic surgery a variety of accessories are available. (See Table 5-1 below). As main accessory the ULITE PHACO HANDPIECE is necessary to perform the surgery. With this handpiece the lens is destroyed by ultrasonic. Furthermore, irrigation and aspiration is provided by the handpiece.

Group	Examples
Accessories for VISALIS V500 / VISALIS S500	Different Footswitches andControls, Drapes and Covers
Accessories for phacoemulsification	Handpiece,Tips, Sleeves, Test Chambers,TIP Wrenches
Accessories for irrigation/aspiration	Irrigation and Aspiration (I/A)handpieces, I/A cannulas incl.sleeves, I/A Tubing sets
Accessories for diathermy and anterior vitrectomy	Diathermy Forceps, Probes toirrigate, cut and aspirate the cutvitreous material
Accessories for retinal surgery	Posterior vitrectomy probes,Trocar kits, Scleral infusioncannulas, irrigation tube sets,Endo-illumination
Accessories for endodiathermy	Endodiathermy probes

ZEISS decided to separate the accessories into groups as followed:

Table 5-1: Groups of Accessories

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Image /page/6/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. The background is a square shape with a curved bottom edge.

INDICATIONS FOR USE (21 CFR §807.92(a)(5))

MAIN DEVICE

The VISALIS V500 and VISALIS S500 Surgical System is indicated for surgical treatment of the anterior segment of the eye by performing irrigation /suction, phacoemulsification of the crystalline lens, anterior vitrectomy and coagulation techniques using bipolar diathermy.

The VISALIS V500 is indicated for use in vitreo-retinal surgery such as retinal detachment and other pathologies of the vitreous body and the posterior segment of the human eye.

ACCESSORIES

ULITE PHACO HANDPIECE

This active re-usable device is an accessory for ZEISS phaco systems. It has been designed to emulsify and aspirate the eye lens during human eye surgery by phacoemulsification technique.

DIATHERMY PROBES

ENDODIATHERMY PROBES

POSTERIOR VITRECTOMY PROBE

This active single use device is an accessory of ZEISS phaco systems with posterior segment functionality. It has been designed to cut and aspirate the vitreous humor through its cutting human eye surgery.

ENDOILLUMINATION PROBES

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Image /page/7/Picture/0 description: The image features the word "ZEISS" in a bold, sans-serif font. The word is white and is set against a solid dark blue background. The background extends beyond the word, creating a rectangular shape. The bottom of the image has a curved white shape, which could be part of a lens or other optical element, suggesting a connection to the company's focus on optics and related technologies.

RISK MANAGEMENT

Risk management is ensured via a risk analysis, which is used to identify potential hazards and mitigations. These potential hazards are controlled by design means, protection measures and user instructions. To confirm that the measures are effective and that the product meets its intended uses, verification of requirements and standards, and validation of the clinical was performed. Carl Zeiss Meditec adheres to recognized and established industry practice and relevant international standards where indicated.

The device labeling contains instructions for use and any necessary cautions and warnings for safe and effective use of the device.

VISALIS V500 / VISALIS S500 is provided with an Instruction for Use. In this Instruction for Use the available accessory is listed.

Every accessory or accessory set is provided with a separate Instruction for Use.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE (21 CFR §807.92(a) (6))

Substantial Equivalence is demonstrated to ALCON CONSTELLATION® Vision System (K141065). This predicate has not been subject to a design-related recall.

Each ophthalmic system is designed to be used for the anterior segment of the eye. However, the ZEISS device is not yet equipped with a laser source.

Both systems are provided with various accessories, in particular with a handpiece for emulsification of the lens. A general overview is given in the following comparison table:

Criteria	VISALIS V500 / VISALIS S500	ALCON CONSTELLATION ® Vision System
Design Aspects
Hardware	- Illumination- Irrigation / Aspiration- Vitrectomy- Diathermy- Ultrasound- Air tamponate- Silicone tamponade	- Illumination- Irrigation / Aspiration- Vitrectomy- Diathermy- Ultrasound- Air tamponate- Silicone tamponade- Laser

Irrigation
Liquid supply: -	- Gravity irrigation- Controlled irrigation- Combined irrigation	- Pressurized Infusion only

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Image /page/8/Picture/0 description: The image shows the logo for Zeiss, a German manufacturer of optical systems and optoelectronics. The logo consists of the word "ZEISS" in a bold, sans-serif font, set against a dark blue background. The background is shaped like a banner or flag, with a curved bottom edge. The overall design is simple, clean, and recognizable, reflecting the company's focus on precision and quality.

Criteria	VISALIS V500 / VISALISS500	ALCON CONSTELLATION ®Vision System
Aspiration
Types of aspiration pumps:	Peristaltic and Venturi pump	Perestaltic pump

Phacoemulsification
Type of handpiece:	piezoelectrical	piezoelectrical

Diath (Diathermy)
Operating frequency:	2 MHz (± 20 %)
	1.5 Mhz ± 10%.

Vit (Vitrectomy)
Cutting mode:	Back-and-forthSingle cut mode available	3D, Momentary, PropVac, VitWetSingle cut mode available

Scissors
Cutting mode:	Horizontal scissors	Proportional, Multi-Cut

Air infusion
Pressure source:	integral rotary vanecompressor	From external source
Silicone oil injection
Pressure source:	Compressed air from externalsource	From external source

Illumination
Type:	Two independent lightsources	One light source
Color temperature:	Lamp 1: 4300 KLamp 2: 5000 K	Just one color temperature
Filters:	Green filter, retina protectionfilter (blue barrier filter)	Fixed UV and IR filters
Safety filter:	IR-UV-blocking filter	Fixed UV and IR filters

Table 5-2: General Comparison Table

Evaluation performed on the VISALIS V500 / VISALIS S500 supports the indications for use statement and demonstrates that the device is substantially equivalent to the predicate device and does not raise new questions regarding safety and effectiveness.

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Image /page/9/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 square background. The logo is simple and modern.

SUMMARY OF PERFORMANCE DATA (21 CFR §807.92(B))

The following performance data were provided in support of the substantial equivalence determination.

. ISO 14971:2007 is a general standard with no specific test acceptance criteria. This standard was used to demonstrate compliance with risk management processes and to support ANSI/AAMI ES60601-1 and IEC 60601-1-2.

ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, ● C1:2009/(R)2012 and A2:2010/(R)2012

Basic safety and essential performance has been evaluated for the VISALIS V500 / VISALIS S500. VISALIS V500 / VISALIS S500 has been found to be in compliance with the ANSI/AAMI ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R) 2012 standard.

IEC 60601-1-2:2014

Electromagnetic compatibility (EMC) has been evaluated for VISALIS V500 / VISALIS S500. VISALIS V500 / VISALIS S500 has been found to be in compliance with the IEC 60601-1-2:2007 standard.

. IEC 60601-2-2:2017

The particular requirements for high frequency surgical equipment and high frequency accessories were evaluated for VISALIS V500 / VISALIS S500 and applicable accessories. VISALIS V500 / VISALIS S500 as well as the applicable accessories has been found to be in compliance with the IEC 60601-2-2:2017 standard.

IEC 80601-2-58:2008 ●

IEC 80601-2-58, applicable for lens removal devices and vitrectomy devices has been evaluated for the VISALIS V500 / VISALIS S500 and applicable accessories. The VISALIS V500 / VISALIS S500 has been found to be in compliance with the IEC 80601-2-58 standard.

IEC 62304:2006/A1:2015 ●

The Software for the VISALIS V500 / VISALIS S500 was documented and tested according to IEC 62304. Details can be found under Section 16 of this submission. The device and its software has been found to be in compliance with IEC 62304 standard.

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Image /page/10/Picture/0 description: The image features the ZEISS logo, which is displayed in white text against a solid blue background. The word "ZEISS" is written in a bold, sans-serif font, with each letter clearly defined. The blue background is a solid, uniform color, providing a stark contrast that makes the logo stand out prominently.

● IEC 62366-1:2015

IEC 62366 is a general standard with no specific test acceptance criteria. This standard was used to demonstrate compliance with the usability requirements of the VISALIS V500 / VISALIS S500 and its accessories.

IEC 15752:2010 ●

IEC 15752, applicable for the endoilluminators and that optical radiation safety has been evaluated for the VISALIS V500 / VISALIS S500 and applicable accessories. The VISALIS V500 / VISALIS S500 as well as the applicable accessories has been found to be in compliance with the IEC 15752 standard.

Biocompatibility evaluations of materials coming in contact with the patient fluid path have been performed to the following standards:

ISO 10993-1:2009 .

ISO 10993-1:2009, applicable for the accessories coming in contact with the patient has been evaluated. The applicable accessories have been found to be in compliance with the ISO 10993-1 standard.

. ISO 10993-5:2009

ISO 10993-5:2009, applicable for the accessories coming in contact with the patient has been evaluated. The applicable accessories have been found to be in compliance with the ISO 10993-5 standard.

● ISO 10993-10:2010

ISO 10993-10:2009, applicable for the accessories coming in contact with the patient has been evaluated. The applicable accessories have been found to be in compliance with the ISO 10993-10 standard.

. ST72:2011/(R)2016

ST72, applicable for the accessories coming in contact with the patient has been evaluated. The applicable accessories have been found to be in compliance with the ST72 standard.

● ISO 17665-1:2006

ISO 17665-1, applicable for re-processable accessories has been evaluated. The applicable accessories have been found to be in compliance with the ISO 17665-1 standard.

. ISO 11135: 2014

ISO 11135, applicable for ETO sterilized accessories has been evaluated. The applicable accessories have been found to be in compliance with the ISO 11135 standard.

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Image /page/11/Picture/0 description: The image shows the logo for Zeiss, a German manufacturer of optical systems and optoelectronics. The logo consists of the word "ZEISS" in a bold, sans-serif font. The text is white and is set against a solid blue square. The logo is simple, clean, and easily recognizable.

● ISO 10993-7:2008-10

ISO 10993-7, applicable for ETO sterilized accessories has been evaluated. The applicable accessories have been found to be in compliance with the ISO 10993-7 standard.

ISO 11737-2:2009 ●

ISO 11737-2, applicable for sterilized accessories has been evaluated. The applicable accessories have been found to be in compliance with the ISO 11737-2 standard.

● F88/F88M-15

F88/F88M-15, applicable for sterilized accessories has been evaluated. The applicable accessories have been found to be in compliance with the F88/F88M standard.

● F1929-2015

F1929, applicable for sterilized accessories has been evaluated. The applicable accessories have been found to be in compliance with the F1929 standard.

Conclusion

The non-clinical data support the safety of the device and the hardware verification and validation demonstrate that the VISALIS V500 / VISALIS S500 should perform as intended in the specified use conditions.

The data demonstrate that the VISALIS V500 / VISALIS S500 performs comparably to the predicate device that is currently marketed for the same intended use.

SUBSTANTIAL EQUIVALENCE TO PREDICATE (21 CFR §807.92(B)(1))

As previously indicated VISALIS V500 / VISALIS S500 has been tested to meet the product requirements and is considered to be substantially equivalent to the predicate as indicated above.

SUMMARY (21 CFR §807.92(C))

In summary, based on the successful verification and validation testing, it is Carl Zeiss Meditec AG's opinion that VISALIS V500 / VISALIS S500 does not introduce any new potential safety risks and is substantially equivalent to, and performs as well as, the predicate device.

Additionally, all testing deemed necessary was conducted on VISALIS V500 / VISALIS S500 to ensure that the device is as safe and effective when used in accordance with its Instructions for Use as the predicate device.

Regulation Number and Section

§ 886.4670 Phacofragmentation system.

(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.