← Product Code [HQC](/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC) · K233876 # UNITY VCS (8065000296); UNITY CS (8065000297) (K233876) _Alcon Laboratories, Inc. · HQC · Jun 21, 2024 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K233876 ## Device Facts - **Applicant:** Alcon Laboratories, Inc. - **Product Code:** [HQC](/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC.md) - **Decision Date:** Jun 21, 2024 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.4670 - **Device Class:** Class 2 - **Review Panel:** Ophthalmic - **Attributes:** Therapeutic ## Intended Use The UNITY VCS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e. vitreoretinal) ophthalmic surgery. In addition, with the optional laser this system is indicated for photocoagulation (i.e. vitreoretinal and macular pathologies), iridotomy, and trabeculoplasty procedures. The UNITY CS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) ophthalmic surgery. ## Device Story Multifunctional surgical consoles for anterior and posterior segment ophthalmic surgery; UNITY VCS supports both, UNITY CS supports anterior only. Systems drive handpieces for tissue cutting, lens emulsification, illumination, and diathermy coagulation. Inputs include touchscreen, remote control, and foot controllers; flow/vacuum-controlled aspiration and pressure-controlled irrigation/infusion manage ocular fluid. Optional integrated 532-nm green laser module for UNITY VCS performs photocoagulation, iridotomy, and trabeculoplasty. Used in clinical/hospital settings by ophthalmic surgeons. Output provides real-time surgical control and visualization integration (e.g., NGENUITY 3D, LuxOR, Verion). Benefits include precise fluidics management and integrated surgical capabilities, reducing need for multiple consoles. System uses RFID for accessory recognition and e-Connectivity for data management. ## Clinical Evidence No clinical data. Substantial equivalence supported by non-clinical bench testing, including biocompatibility (ISO 10993), sterilization validation, electromagnetic compatibility (IEC 60601-1-2), electrical/mechanical safety (IEC 80601-2-58), and software verification/validation (IEC 62304). ## Technological Characteristics Multifunctional surgical consoles; 100-240V AC power. Features: touchscreen, foot control, remote, RFID accessory detection, e-Connectivity. Fluidics: flow/vacuum/pressure control. Ultrasound: longitudinal/torsional phaco. Laser: 532-nm green. Diathermy: 1.5 MHz, 75 ohm, 10W. Sterilization: Ethylene Oxide for accessories. Software: IEC 62304 compliant. ## Regulatory 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. ## Predicate Devices - CONSTELLATION Vision System ([K141065](/device/K141065.md)) - Next-Generation Laser ([K062624](/device/K062624.md)) - CENTURION Vision System with Active Sentry ([K161794](/device/K161794.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. June 21, 2024 Alcon Laboratories, Inc. Ganesh Balachandar Regulatory Affairs Manager 6201 South Freeway Fort Worth, Texas 76134 Re: K233876 Trade/Device Name: UNITY VCS (8065000296); UNITY CS (8065000297) Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation system Regulatory Class: Class II Product Code: HQC, HQE, HQF Dated: May 17, 2024 Received: May 20, 2024 Dear Ganesh Balachandar: 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. {1}------------------------------------------------ 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. 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. 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. {2}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Claudine H. Krawczyk -S Claudine Krawczyk Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K233876 Device Name UNITY VCS (8065000296) ; UNITY CS (8065000297) #### Indications for Use (Describe) UNITY VCS The UNITY VCS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e. vitreoretinal) ophthalmic surgery. In addition, with the optional laser this system is indicated for photocoagulation (i.e. vitreoretinal and macular pathologies), iridotomy, and trabeculoplasty procedures. #### UNITY CS The UNITY CS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) ophthalmic surgery. | 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. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ In accordance with 21 CFR 807.92, Alcon hereby provides the 510(k) summary for the UNITY VCS and UNITY CS. # 1. SUBMITTER | Applicant | Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134-2099 | |-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Primary Correspondent | Ganesh Balachandar, M.S.
Regulatory Affairs Manager
Alcon Research LLC,
on behalf of Alcon Laboratories, Inc.
20511 Lake Forest Drive
Lake Forest, CA 92630-7741
+1 (949) 322-5101
ganesh.balachandar@alcon.com | | Secondary Correspondent | Ophelia Biggs
Director, Regulatory Affairs
Alcon Research LLC,
on behalf of Alcon Laboratories, Inc.
20511 Lake Forest Drive
Lake Forest, CA 92630-7741
+1 (949) 217-3854
ophelia.biggs@alcon.com | | Date Prepared | June 21, 2024 | {5}------------------------------------------------ # 2. SUBJECT DEVICES | Device Trade Name | UNITY VCS (8065000296);
UNITY CS (8065000297) | |-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification
Number and Name
(Product Code in
Parentheses) | For UNITY VCS:
• 21 CFR 886.4150, Vitreous aspiration and cutting instrument
(HQE)
• 21 CFR 886.4670, Phacofragmentation system (HQC)
• 21 CFR 886.4690, Ophthalmic laser (HQF)
For UNITY CS:
• 21 CFR 886.4670, Phacofragmentation system (HQC) | | Regulatory Class | II | # 3. PREDICATE DEVICES | FOR UNITY VCS: | | |-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------| | Predicate Device | CONSTELLATION Vision System | | 510(k) Number | K141065 | | Classification
Number and Name
(Product Code in
Parentheses) | 21 CFR 886.4150, Vitreous aspiration and cutting instrument (HQE) 21 CFR 886.4670, Phacofragmentation system (HQC) | | Regulatory Class | II | | FOR UNITY VCS (Laser Functionality): | | |-----------------------------------------------------------------------|--------------------------------------------| | Predicate Device | Next-Generation Laser | | 510(k) Number | K062624 | | Classification
Number and Name
(Product Code in
Parentheses) | • 21 CFR 886.4390, Laser, Ophthalmic (HQF) | | Regulatory Class | II | | FOR UNITY CS: | | |------------------|--------------------------------------------------| | Predicate Device | CENTURION Vision System with Active Sentry | | 510(k) Number | K161794 | | Classification | 21 CFR 886.4670, Phacofragmentation system (HQC) | {6}------------------------------------------------ | Number and Name
(Product Code in
Parentheses) | | |-----------------------------------------------------|----| | Regulatory Class | II | {7}------------------------------------------------ #### DEVICE DESCRIPTION 4. The UNITY VCS is a multifunctional surgical instrument for use in anterior and posterior segment ophthalmic surgeries. The capabilities of the UNITY VCS include driving a variety of handpieces that provide the ability to cut vitreous and tissues, emulsify the crystalline lens, illuminate the posterior segment of the eye, and apply diathermy to stop bleeding. Flow-controlled or vacuumcontrolled aspiration is used to remove ocular matter from the eye. Pressure-controlled irrigation/infusion capability is provided to replace fluid in the eye and enters the eye directly through either an infusion cannula or a handpiece. The graphical user interface is menu-driven. The operator provides inputs using the touchscreen panel, the remote control, and the foot controllers. An optional, fully integrated laser module is available that can be installed in the base of the UNITY VCS configuration for vitreoretinal surgery. The laser delivers the same visible 532-nm green treatment beam designed for ophthalmic use as in the predicate device. When used with compatible components and accessories, the system will perform anterior and posterior segment ophthalmic procedures, including irrigation, phacoemulsification, extraction, vitrectomy, diathermy coagulation, intraocular illumination, photocoagulation, viscous fluid control, tissue grabbing and cutting. The UNITY CS is a multifunctional surgical instrument for use in anterior segment ophthalmic surgeries. The capabilities of the UNITY CS include driving a variety of handpieces that provide the ability to cut anterior vitreous and tissues, emulsify the crystalline lens, and apply diathermy to stop bleeding. Flow-controlled or pressure-controlled aspiration is used to remove ocular matter from the eye. Pressure-controlled irrigation/infusion capability is provided to replace fluid in the eye and enters the eye directly through either an infusion cannula or a handpiece. The graphical user interface is menu-driven, and the operator provides inputs using the touchscreen panel, the remote control, and the foot controllers. When used with compatible components and accessories, the system will perform anterior segment ophthalmic procedures, including irrigation, phacoemulsification, extraction, vitrectomy, and diathermy coagulation. The UNITY VCS and UNITY CS are intended to be used within a clinic(s)/hospital(s)/surgical practice network. Both devices are for prescription use only. #### INDICATIONS FOR USE ડાં ### UNITY VCS: The UNITY VCS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e. {8}------------------------------------------------ vitreoretinal) ophthalmic surgery. In addition, with the optional laser this system is indicated for photocoagulation (i.e. vitreoretinal and macular pathologies), iridotomy and trabeculoplasty procedures. ### UNITY CS: The UNITY CS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) ophthalmic surgery. {9}------------------------------------------------ #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS TO PREDICATE 6. | Characteristic | CONSTELLATION
Vision System
(Predicate Device for
Subject Device 1) | UNITY VCS
(Subject Device 1) | CENTURION Vision
System with Active
Sentry (Predicate Device
for Subject Device 2) | UNITY CS
(Subject Device 2) | |-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Administrative | | | | | | 510(k) | K141065 | K233876 | K161794 | K233876 | | Intended Use | Anterior and posterior
segment ophthalmic
surgery | Same
(The subject device,
consisting of the console
and compatible devices, is
intended to facilitate
management of fluid and
gases, as well as removal,
grasping, cutting,
illumination, and
coagulation of ocular
materials)1 | Anterior segment
ophthalmic surgery | Same
(The subject device,
consisting of the console
and compatible devices, is
intended to facilitate
management of fluid as
well as removal, cutting,
and coagulation of ocular
materials)1 | | Indications for Use | The CONSTELLATION®
Vision System is indicated
for the following:
The CONSTELLATION®
Vision System is an
ophthalmic microsurgical
system that is indicated for
both anterior segment (i.e.
phacoemulsification and | The UNITY VCS console,
when used with
compatible devices, is
indicated for use during
anterior segment (i.e.
phacoemulsification and
removal of cataracts) and
posterior segment (i.e.
vitreoretinal) ophthalmic | The Centurion Vision
System is indicated for
emulsification, separation,
irrigation, and aspiration
of cataracts, residual
cortical material and lens
epithelial cells, vitreous
aspiration and cutting
associated with anterior | The UNITY CS console,
when used with
compatible devices, is
indicated for use during
anterior segment (i.e.
phacoemulsification and
removal of cataracts)
ophthalmic surgery. | | Characteristic | CONSTELLATION
Vision System
(Predicate Device for
Subject Device 1) | UNITY VCS
(Subject Device 1) | CENTURION Vision
System with Active
Sentry (Predicate Device
for Subject Device 2) | UNITY CS
(Subject Device 2) | | | removal of cataracts) and
posterior segment (i.e.,
vitreoretinal) ophthalmic
surgery in addition to the
indications included with
the optional Next-
Generation laser. The
AutoSert® IOL Injector
Handpiece is intended to
deliver qualified
ACRYSOF® intraocular
lenses into the eye
following cataract
removal.
The AutoSertⓇ
IOL Injector Handpiece
achieves the functionality
of injection of intraocular
lenses. The AutoSert is
indicated for use with
ACRYSOF® lenses
SN60WF, SN6AD1,
SN6AT3 through
SN6AT9, as well as
approved ACRYSOF®
lenses that are specifically
indicated for use with this
inserter as indicated in the | surgery.

In addition, with the
optional laser this system
is indicated for
photocoagulation (i.e.
vitreoretinal and macular
pathologies), iridotomy
and trabeculoplasty
procedures.2 | vitrectomy, bipolar
coagulation, and
intraocular lens injection.
The AutoSert IOL Injector
Handpiece is intended to
deliver qualified AcrySof
intraocular lenses into the
eye following cataract
removal.

The AutoSert IOL Injector
Handpiece achieves the
functionality of injection
of intraocular lenses. The
AutoSert IOL Injector
Handpiece is indicated for
use with the AcrySof
lenses SN60WF,
SNWAD1, SN6AT3
through SN6AT9,
as well as approved
AcrySof lenses that are
specifically indicated for
use with this inserter, as
indicated in the approved
labeling of those lenses. | | | Characteristic | CONSTELLATION
Vision System
(Predicate Device for
Subject Device 1) | UNITY VCS
(Subject Device 1) | CENTURION Vision
System with Active
Sentry (Predicate Device
for Subject Device 2) | UNITY CS
(Subject Device 2) | | | approved labeling of those
lenses. | | | | | Console Features | | | | | | Monolith | Yes | Yes | Yes | Yes | | Tray | Yes | Yes | Yes | Yes | | Touch Panel Display | Yes | Yes | Yes | Yes | | RFID for accessory
connections | Yes | Yes | No | Yes | | e-Connectivity | Yes | Yes | Yes | Yes | | User Interface | Touch panel display, foot
controllers, remote control | Same | Same | Same | | Electrical Power
Specifications | 100-240 V AC, 50/60 Hz | Same | Same | Same | | Operating
Temperature Range | 10-35°C | Same | Same | Same | | Console Height,
Width and Depth | Height: 62.4"
Width: 30.3"
Depth: 36" | Height: 64.6"
Width: 25.4"
Depth:28.3" | Height:64.6"
Width:19.6'
Depth:31.6" | Height: 64.6"
Width: 25.4"
Depth:28.3" | | Maximum Humidity
(RH = Relative
Humidity) | 95% RH non-condensing | Same | Same | Same | | Fluidics Features | | | | | | Push Prime | Yes | Yes | No | Yes | | Infusion/Irrigation
Source Change | Yes | Yes | Yes | Yes | | Aspiration Pressure
Control | Yes | Yes | Yes | Yes | | Aspiration Flow
Control | Yes | Yes | Yes | Yes | | Characteristic | CONSTELLATION
Vision System
(Predicate Device for
Subject Device 1) | UNITY VCS
(Subject Device 1) | CENTURION Vision
System with Active
Sentry (Predicate Device
for Subject Device 2) | UNITY CS
(Subject Device 2) | | Suction Flow
Control | Yes | Yes | No | No | | Flow Control –
Irrigation | No | Yes | Yes | Yes | | Flow Control –
Infusion | No | Yes | No | No | | IOP-Controlled
Infusion/Irrigation | Yes | Yes | Yes | Yes | | Pressurized Infusion
Irrigation | Yes | Yes | No | No | | | Yes | Yes | Yes | Yes | | Proportional Reflux | Yes | Yes | No… --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K233876](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K233876) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com