Who is the manufacturer of STELLARIS PC VISION ENHANCEMENT SYSTEM?

Bausch & Lomb filed the 510(k) submission for STELLARIS PC VISION ENHANCEMENT SYSTEM (K133486).

What is the FDA product code for STELLARIS PC VISION ENHANCEMENT SYSTEM?

HQC. It is classified under 21 CFR 886.4670 as a Class 2 device in the Ophthalmic panel.

What is the regulatory pathway for STELLARIS PC VISION ENHANCEMENT SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for STELLARIS PC VISION ENHANCEMENT SYSTEM?

Stellaris PC Vision Enhancement System (K101325); Millenium Microsurgical System (K022760); Family of IRIDEX IQ Laser Systems (1Q532, 1Q577, IQ 630-670, 1Q8 10) (K071687).

Who can help prepare an FDA 510(k) submission like STELLARIS PC VISION ENHANCEMENT SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

STELLARIS PC VISION ENHANCEMENT SYSTEM

K133486 · Bausch & Lomb · HQC · Mar 12, 2014 · Ophthalmic

Device Facts

Record ID	K133486
Device Name	STELLARIS PC VISION ENHANCEMENT SYSTEM
Applicant	Bausch & Lomb
Product Code	HQC · Ophthalmic
Decision Date	Mar 12, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 886.4670
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Bausch & Lomb StellarisPC Vision Enhancement System is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, bipolar coagulation, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. The laser modes are intended for retinal photocoagulation and laser trabeculaplasty.

Device Story

Integrated ophthalmic microsurgical system for anterior and posterior segment surgery; performs phacoemulsification, vitrectomy, irrigation/aspiration, bipolar coagulation, viscous fluid management, and air/fluid exchange. Includes optional 532nm laser module for photocoagulation and trabeculoplasty. Operated by surgeons in clinical settings via LCD touchscreen and footswitch. System integrates hardware (power supply) and software revisions to existing Stellaris PC platform. Provides real-time surgical control; enhances procedural efficiency by combining anterior and posterior segment capabilities in one unit.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included electrical safety (IEC 60601-1, 60601-2-58, 60601-2-2, 60601-2-22), laser safety (IEC 60825-1), usability (IEC 62366), and software verification/validation. Functional and simulated use testing confirmed requirements met.

Technological Characteristics

Integrated ophthalmic surgical system; LCD touchscreen interface; footswitch control. Electrical: 90-130 VAC or 200-240 VAC, 50/60 Hz. Includes 532nm laser module. Compliance with IEC 60601-1, 60601-2-58, 60601-2-2, 60601-2-22, IEC 60825-1, IEC 60601-1-6, and IEC 62366.

Indications for Use

Indicated for patients requiring cataract emulsification/removal, anterior and posterior segment vitrectomy, retinal photocoagulation, and laser trabeculoplasty. Used in anterior and posterior segment ophthalmic surgeries.

Regulatory Classification

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

Stellaris PC Vision Enhancement System (K101325)
Millenium Microsurgical System (K022760)
Family of IRIDEX IQ Laser Systems (1Q532, 1Q577, IQ 630-670, 1Q8 10) (K071687)

Related Devices

K170052 — Stellaris Elite vision enhancement system · Bausch+Lomb · Apr 19, 2017
K162342 — Stellaris Elite Vision Enhancement System · Bausch+Lomb · Mar 24, 2017
K252052 — Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) · Bausch and Lomb, Incorporated · Mar 25, 2026
K232084 — Stellaris Elite vision enhancement system · Bausch and Lomb · Feb 26, 2024
K101325 — STELLARIS PC VISION ENHANCEMENT SYSTEM · Bausch & Lomb, Inc. · Aug 17, 2010

Submission Summary (Full Text)

{0}------------------------------------------------ ## BAUSCH + LOMB See better. Live better. ### 1. General Information #### Section 8-510(k) Summary | Submitter: | Contact Person: | |-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------| | Bausch + Lomb Inc. 3365 Tree Court Industrial Blvd. St. Louis MO 63122 General Telephone: 636-226-3017 | Timothy W Capehart 636-226-3017 (Office) 636-226-3245 (Fax) Timothy.Capehart@bausch.com | | Preparation Date: November 6, 2013 | | 2. Names | Device Name(s): | Stellaris® PC Vision Enhancement System | |-------------------------|---------------------------------------------------------------------| | Classification Name(s): | Phacofragmentation Unit, Vitreous Aspiration and Cutting Instrument | | Common Name: | Ophthalmic surgical system for cataract and vitreo-retinal surgery | | CFR References: | 21 CFR 886.4670, 21 CFR 886.4150, 21 CFR 886.4390 | | Product Codes: | HQC, HQE, HQF | ### 3. Predicate Devices - K101325 Stellaris PC Vision Enhancement System, Bausch & Lomb . - K022760 Millenium Microsurgical System, Bausch & Lomb . - K071687 Family of IRIDEX IQ Laser Systems (1Q532, 1Q577, IQ 630-670, 1Q8 10) & . Delivery Device Accessories #### 4. Product Description The Bausch + Lomb Stellaris PC Vision Enhancement System is an integrated ophthalmic microsurgical system designed for use in anterior and posterior segment surgery including phacofragmentation and vitreous aspirating and cutting as well as endoillumination. Additionally, this model includes an optional 532nm laser module for photocoagulation. The system is based on the technology and the performance of the existing Stellaris PC Vision Enhancement System, and this traditional 510(k) incorporates software revisions, a hardware revision to the power supply, and the additional of an optional laser photocoagulation module. The system enhances the ability to perform as one combined anterior and posterior system for increased efficiency. #### 5. Indications for Use The Bausch & Lomb Stellaris PC Vision Enhancement System is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, bipolar coagulation, viscous fluid injection/removal and air/fluid exchange operations. The laser modes are intended for retinal photocoagulation and laser trabeculaplasty. {1}------------------------------------------------ # BAUSCH+LOMB ## See better. Live better. ## Section 8-510(k) Summary ### 6. Summary of Technological Characteristics The technological characteristics of the Stellaris PC Vision Enhancement System are substantially equivalent to those of the predicate device. | Characteristic | Subject Device Stellaris®PC Vision Enhancement System | K101325 Stellaris®PC Vision Enhancement System | K022760 Millennium Laser Photocoagulator System | K071687 Iridex IQ Laser Family | |-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Anterior/Posterior ophthalmic surgery | Anterior/Posterior ophthalmic surgery | Intended for use in ophthalmic procedures | Intended for use in ophthalmic and dermatologic al procedures (Ophthalmic 532nm only) | | Indications for Use | The Bausch + Lomb Stellaris®PC Vision Enhancement System is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, bipolar coagulation, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. The laser modes are intended for retinal photocoagulation and laser trabeculaplasty. | The Bausch & LombTM Stellaris® PC Vision Enhancement System device is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phaco fragmentation (coaxial or bimanual), irrigation/aspiration, bipolar diathermy, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. Uses only Bausch & Lomb disposable packs and handpieces designated for use with the system- | The laser modes are intended for retinal photocoagulation and laser trabeculaplasty. Delivery devices available are the Endoprobe for intraocular endolaser surgery, and the Laser Indirect Ophthalmoscope Plus (LIO+) for transpupillary laser delivery for patients in the supine position. | Indicated for retinal photocoagula tion, laser trabeculoplast y, iridotomy, iridoplasty including: • Retinal photocoagula tion (RPC) for the treatment of > Diabetic retinopathy, including: Nonproliferat ive retinopathy - Macular edema -Proliferative retinopathy > Retinal tears and detachments > Lattice degeneration > Age-related macular degeneration (AMD) > Retinopathy of | | Characteristic | Subject Device Stellaris®PC Vision Enhancement System | K101325 Stellaris®PC Vision Enhancement System | K022760 Millennium Laser Photocoagulator System | K071687 Iridex IQ Laser Family | | | | | | prematurity > Sub-retinal (choroidal) neovascularization > Central and branch retinal vein occlusion · Laser trabeculoplasty, iridotomy, iridoplasty for the treatment of glaucoma, including > Primary open angle/Closed angle | | Laser capabilities | Yes | No | Yes | Yes | | User interface | LCD touch screen | LCD touch screen | NA | LCD touchscreen | | Footswitch | Yes | Yes | Yes | Yes | | Electrical Characteristics | 90-130 VAC, 50/60 Hz 200-240 VAC, 50/60 Hz | 90-130 VAC, 50/60 Hz 200-240 VAC, 50/60 Hz | 90-130 VAC, 50/60 Hz 200-240 VAC, 50/60 Hz | 90-130 VAC, 50/60 Hz 200-240 VAC, 50/60 Hz | {2}------------------------------------------------ # BAUSCH+LOMB ## See better. Live better. #### Section 8 -510(k) Summary {3}------------------------------------------------ # BAUSCH + LOMB See better. Live better. ### 7. Safety and Effectiveness Information #### The review of the indications for use and technical characteristics provided demonstrates that the Stellaris PC Vision Enhancement System is substantially equivalent to the predicate devices and is safe and effective for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy . #### 8. Brief Summary of Nonclinical Tests and Results Safety tests of the Stellaris PC Vision Enhancement System have demonstrated its compliance with applicable requirements of the following electrical standards: | IEC 60601-1:2005 + C1(2006) + C2(2007) + AM1(2012) | Medical electrical equipment - Part 1 : General requirements for basic safety and essential performance | |-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | or IEC 60601-1:2012 | | | IEC 80601-2-58:2008 | Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery | | IEC 60601-1-6:2010 | Medical electrical equipment. Part 1-6: General requirements for basic safety and essential performance. Collateral standard. Usability | | IEC 62366:2007 | Medical devices - Application of usability engineering to medical devices | | IEC 60601-2-2:2009 | Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories | | IEC 60601-2-22:2007 | Medical electrical equipment - Part 2-22: Particular requirements for the safety of diagnostic and therapeutic laser equipment | | IEC 60825-1:2007 | Safety of laser products - Part 1: Equipment classification and requirements | Functional, simulated use, environmental and transport testing were also performed on representative units. Software changes were verified and validated in accordance with the Bausch & Lomb software quality procedures which comply with EN ISO IEC 62304:2006 Medical device software -- Software life cycle processes. The Stellaris PC Vision Enhancement System passed all of the above tests with no exceptions. This testing demonstrates that the functional requirements have been met and that the modified device is equivalent to the predicate device. #### Premarket Notification Traditional 510(k) Bausch + Lomb Stellaris®PC Vision Enhancement System ## Section 8-510(k) Summary {4}------------------------------------------------ # BAUSCH + LOMB See better. Live better. #### Section 8 -- 510(k) Summary ## 9. Conclusion The Stellaris®PC Vision Enhancement System shares identical indications for use, similar design features, and functional features with, and thus is substantially equivalent to, the predicate devices. {5}------------------------------------------------ Public Health Service DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G109 Silver Spring, MD 20993-0002 March 12, 2014 Bausch + Lomb, Inc. % Mr. Timothy W. Capehart Manger Regulatory Affairs. Equipment and Instruments 3365 Tree Court Industrial Boulevard Saint Louis, MO 63122 Re: K133486 Trade/Device Name: Stellaris PC Vision Enhancement System Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation system. Regulatory Class: Class II Product Code: HQC, HQE, HQF Dated: February 5, 2014 Received: February 7, 2014 Dear Mr. Capehart: 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. 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. {6}------------------------------------------------ Page 2 - Mr. Timothy W. Capehart You must comply with all the Act's requirements, including, but not limited to: Registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/McdicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Kesia Y. Alexander -S for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page. #### 510(k) Number (if known) #### K133486 #### Device Name Stellaris®PC Vision Enhancement System #### Indications for Use (Describe) The Bausch & Lomb StellarisPC Vision Enhancement System is intended for the emulsification and removal of catarior and posterior segment virectory. The system is designed for use in both anterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimigation, bipolar coagulation, virectory, viscous fluid injection/removal and sir/fluid exchange operations. The laser modes are intended for retinal photocoagulation and laster trabeculaplasty. 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) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. SE SERVER SELLER SECTION FOR FOR FOR FOR FOR FOR FOR FOR FOR SECTION OF CONSEL Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure) # Rahul K. Ram -S (A 2014.03.11 17:38:33 FORM FDA 3881 (9/13)