← Product Code [HQC](/productcode/HQC) · K261264 # Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+ (K261264) _Bausch and Lomb · HQC · May 15, 2026 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K261264 ## Device Facts - **Applicant:** Bausch and Lomb - **Product Code:** [HQC](/productcode/HQC.md) - **Decision Date:** May 15, 2026 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 886.4670 - **Device Class:** Class 2 - **Review Panel:** Ophthalmic - **Attributes:** Therapeutic ## Indications for Use The Bausch + Lomb Stellaris Elite™ 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 Stellaris Elite™ Vision Enhancement System configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty. The Bausch + Lomb posterior and combined procedure packs are intended for use with the Bausch + Lomb Stellaris Vision Enhancement Systems which are intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. They provide capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, vitrectomy, and air/fluid exchange operations. The Bausch + Lomb Light Pipes are intended for use with the Bausch + Lomb Stellaris Vision Enhancement Systems for use during anterior and posterior segment surgeries. ## Device Story Stellaris Elite™ is an integrated ophthalmic microsurgical system for anterior and posterior segment surgery; performs phacoemulsification, vitrectomy, irrigation/aspiration, bipolar coagulation, viscous fluid injection/removal, and air/fluid exchange. System may include laser module for retinal photocoagulation and trabeculoplasty. Disposable procedure packs (tubing, cannulas, cutters, probes, drapes) and light pipes facilitate surgical access and illumination. Used in clinical settings by surgeons. System provides fluidics and mechanical control for ocular procedures; light pipes provide intraocular illumination. Output allows surgeon to perform precise tissue removal and visualization. Benefits include improved surgical efficiency and patient outcomes in cataract and vitreo-retinal procedures. ## Clinical Evidence No clinical or animal studies were performed. Substantial equivalence is supported by bench testing, including transportation/packaging validation, sterilization validation, and biocompatibility assessments. ## Technological Characteristics System components include disposable procedure packs and light pipes (23, 25, 27 gauge). Materials are biocompatible per ISO 10993-1. Sterilization via Gamma Irradiation (packs) or Ethylene Oxide (light pipes/pouches). Packaging uses HIPS trays with Tyvek lids or Tyvek/Mylar pouches. System supports phacoemulsification, vitrectomy, and laser modules. Connectivity and software architecture are inherited from the predicate Stellaris Elite™ system. ## 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 - Stellaris Elite™ vision enhancement system ([K162342](/device/K162342.md)) ## Reference Devices - Stellaris Elite™ vision enhancement system with Bi-Blade™+ ([K252052](/device/K252052.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} FDA U.S. FOOD & DRUG ADMINISTRATION May 15, 2026 Bausch and Lomb Matthew Harrison Senior Regulatory Affairs Specialist 3365 Tree Ct. Industrial Blvd. Saint Louis, Missouri 63122 Re: K261264 Trade/Device Name: Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425BB+); 27 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427BB+); TSV 23 ga. Posterior Vitrectomy Pack with AFI (BL5423X); TSV 25 ga. Posterior Vitrectomy Pack with AFI (BL5425X); 23 ga. Combined Elite™ Pack (SE5523); 23 ga. Bi-Blade™ Vitreous Cutter Combined Stellaris Elite™ Pack (SE5523B); 25 ga. Combined Elite™ Pack (SE5525); 25 ga. Bi-Blade™ Vitreous Cutter Combined Stellaris Elite™ Pack (SE5525B); 27 ga. Bi-Blade™ Vitreous Cutter Combined Stellaris Elite™ Pack (SE5527B); 23 ga. Bi-Blade™+ Vitreous Cutter Combined Stellaris Elite™ Pack (SE5523BB+); 25 ga. Bi-Blade™+ Vitreous Cutter Combined Stellaris Elite™ Pack (SE5525BB+); 27 ga. Bi-Blade™+ Vitreous Cutter Combined Stellaris Elite™ Pack (SE5527BB+); TSV 23 ga. Combined Vitrectomy Pack with AFI (BL5523X); TSV 25 ga. Combined Vitrectomy Pack with AFI (BL5525X); Light Pipe(s): 23 ga. Mid-Field Light Pipe w/ESA (SE23MV); 25 ga. Mid-Field Light Pipe w/ESA (SE25MV); 27 ga. Mid-Field Light Pipe w/ESA (SE27MV); 23 ga. Wide-Field Light Pipe w/ESA (SE23WV); 25 ga. Wide-Field Light Pipe w/ESA (SE25WV); 27 ga. Wide-Field Light Pipe w/ESA (SE27WV); 23 ga. Wide-Field Light Pipe w/ESA (BL23WV); 25 ga. Wide-Field Light Pipe w/ESA (BL25WV) Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: Class II Product Code: HQC, HQE, MPA Dated: April 15, 2026 Received: April 16, 2026 U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261264 - Matthew Harrison Page 2 Dear Matthew Harrison: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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. {2} K261264 - Matthew Harrison Page 3 All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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 | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K261264 | ? | | --- | --- | --- | | Please provide the device trade name(s). | | ? | Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): - 23 ga. Posterior Elite™ Pack (SE5423); - 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); - 25 ga. Posterior Elite™ Pack (SE5425); - 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); - 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); - 23 ga. Bi-Blade™ + Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); - 25 ga. Bi-Blade™ + Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425BB+); - 27 ga. Bi-Blade™ + Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427BB+); - TSV 23 ga. Posterior Vitrectomy Pack with AFI (BL5423X); - TSV 25 ga. Posterior Vitrectomy Pack with AFI (BL5425X); - 23 ga. Combined Elite™ Pack (SE5523); - 23 ga. Bi-Blade™ Vitreous Cutter Combined Stellaris Elite™ Pack (SE5523B); - 25 ga. Combined Elite™ Pack (SE5525); - 25 ga. Bi-Blade™ Vitreous Cutter Combined Stellaris Elite™ Pack (SE5525B); - 27 ga. Bi-Blade™ Vitreous Cutter Combined Stellaris Elite™ Pack (SE5527B); - 23 ga. Bi-Blade™ + Vitreous Cutter Combined Stellaris Elite™ Pack (SE5523BB+); - 25 ga. Bi-Blade™ + Vitreous Cutter Combined Stellaris Elite™ Pack (SE5525BB+); - 27 ga. Bi-Blade™ + Vitreous Cutter Combined Stellaris Elite™ Pack (SE5527BB+); - TSV 23 ga. Combined Vitrectomy Pack with AFI (BL5523X); - TSV 25 ga. Combined Vitrectomy Pack with AFI (BL5525X); Light Pipe(s): - 23 ga. Mid-Field Light Pipe w/ESA (SE23MV); - 25 ga. Mid-Field Light Pipe w/ESA (SE25MV); - 27 ga. Mid-Field Light Pipe w/ESA (SE27MV); - 23 ga. Wide-Field Light Pipe w/ESA (SE23WV); - 25 ga. Wide-Field Light Pipe w/ESA (SE25WV); - 27 ga. Wide-Field Light Pipe w/ESA (SE27WV); - 23 ga. Wide-Field Light Pipe w/ESA (BL23WV); - 25 ga. Wide-Field Light Pipe w/ESA (BL25WV) Please provide your Indications for Use below. Posterior and Combined Procedure Pack(s): The Bausch + Lomb Stellaris Elite™ 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 Stellaris Elite™ Vision Enhancement System configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty. The Bausch + Lomb posterior and combined procedure packs are intended for use with the Bausch + Lomb {4} Stellaris Vision Enhancement Systems which are intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. They provide capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, vitrectomy, and air/fluid exchange operations. Light Pipe(s): The Bausch + Lomb Stellaris Elite™ 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 Stellaris Elite™ Vision Enhancement System configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty. The Bausch + Lomb Light Pipes are intended for use with the Bausch + Lomb Stellaris Vision Enhancement Systems for use during anterior and posterior segment surgeries. | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | --- | --- | --- | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☐ Adults (22 years old and greater) | ? | {5} BAUSCH + LOMB See better. Live better. 510(k) Summary - K261264 # 510(k) Summary ## 1 General Information | Submitter: | Contact Person: | | --- | --- | | Bausch and Lomb Inc. | Matt Harrison | | 3365 Tree Court Industrial Blvd. | 3365 Tree Court Industrial Blvd. | | Saint Louis, MO 63122 | Saint Louis, MO 63122 | | General Telephone: 636-226-3017 | (636) 200-8807 | | | Matt.Harrison@Bausch.com | Preparation Date: May 15, 2026 ## 2 Names | Device Name: | Stellaris Elite™ vision enhancement system Stellaris Elite™ Posterior and Combined Procedure Packs 23 ga. Posterior Elite™ Pack (SE5423) 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B) 25 ga. Posterior Elite™ Pack (SE5425) 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B) 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B) 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+) 25 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425BB+) 27 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427BB+) 23 ga. Combined Elite™ Pack (SE5523) 23 ga. Bi-Blade™ Vitreous Cutter Combined Stellaris Elite™ Pack (SE5523B) 25 ga. Combined Elite™ Pack (SE5525) 25 ga. Bi-Blade™ Vitreous Cutter Combined Stellaris Elite™ Pack (SE5525B) 27 ga. Bi-Blade™ Vitreous Cutter Combined Stellaris Elite™ Pack (SE5527B) 23 ga. Bi-Blade™+ Vitreous Cutter Combined Stellaris Elite™ Pack (SE5523BB+) 25 ga. Bi-Blade™+ Vitreous Cutter Combined Stellaris Elite™ Pack (SE5525BB+) 27 ga. Bi-Blade™+ Vitreous Cutter Combined Stellaris Elite™ Pack (SE5527BB+) | | --- | --- | | | Stellaris PC Posterior and Combined Procedure Packs TSV 23 ga. Posterior Vitrectomy Pack with AFI (BL5423X) TSV 25 ga. Posterior Vitrectomy Pack with AFI (BL5425X) TSV 23 ga. Combined Vitrectomy Pack with AFI (BL5523X) TSV 25 ga. Combined Vitrectomy Pack with AFI (BL5525X) | | | Light Pipes 23 ga. Mid-Field Light Pipe w/ESA (SE23MV) 25 ga. Mid-Field Light Pipe w/ESA (SE25MV) 27 ga. Mid-Field Light Pipe w/ESA (SE27MV) 23 ga. Wide-Field Light Pipe w/ESA (SE23WV) 25 ga. Wide-Field Light Pipe w/ESA (SE25WV) 27 ga. Wide-Field Light Pipe w/ESA (SE27WV) 23 ga. Wide-Field Light Pipe w/ESA (BL23WV) 25 ga. Wide-Field Light Pipe w/ESA (BL25WV) | | Classification Names: | Phacofragmentation Unit, Vitreous Aspiration and Cutting Instrument | | Common Name: | Ophthalmic surgical system for cataract and vitreo-retinal surgery | | CFR References: | 21 CFR Part 886.4670 - Phacofragmentation System (HQC) | Premarket Notification Special 510(k) Stellaris Elite™ vision enhancement system 510(k) Summary {6} BAUSCH + LOMB See better. Live better. 510(k) Summary - K261264 (Product Codes) 21 CFR Part 886.4150 - Vitreous Aspiration and Cutting Instrument (HQE) 21 CFR Part 876.1500 - Endoscope and Accessories (MPA) # 3 Predicate Devices K162342 – Stellaris Elite™ vision enhancement system, Bausch + Lomb # 4 Reference Devices K252052 – Stellaris Elite™ vision enhancement system with Bi-Blade™+, Bausch + Lomb # 5 Product Description The Bausch + Lomb Stellaris Elite™ vision enhancement system is comprised of an integrated ophthalmic microsurgical system designed for use in anterior and posterior segment surgery including phacofragmentation, vitreous aspirating, cutting, and endoillumination. Additionally, the Stellaris Elite™ vision enhancement system may be configured with a laser module intended for retinal photocoagulation and laser trabeculoplasty. A selection of disposable single-use procedure packs is available for use with the system. These packs contain the necessary tubing to facilitate delivery and removal of air and fluids to and from the patient as well as a selection of components (cannulas, cutters, probes, drapes, etc.) that facilitate the surgical procedure. The items are arranged for physician convenience and may be presented as a group intended to support all the needs of a procedure or packaged singularly to allow the physician greatest flexibility. With this 510(k), Bausch + Lomb is introducing gamma-sterilized Posterior and Combined procedure packs and EO-sterilized Light Pipe and ESA pouches for use with Bausch + Lomb Stellaris Elite™ vision enhancement systems. # 6 Indications for Use ## Posterior and Combined Procedure Packs The Bausch + Lomb Stellaris Elite™ 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 Stellaris Elite™ Vision Enhancement System configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty. The Bausch + Lomb posterior and combined procedure packs are intended for use with the Bausch + Lomb Stellaris Vision Enhancement Systems which are intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. They provide capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, vitrectomy, and air/fluid exchange operations. Premarket Notification Special 510(k) Stellaris Elite™ vision enhancement system 510(k) Summary Page 2 of 3 {7} BAUSCH + LOMB See better. Live better. 510(k) Summary - K261264 # Light Pipes The Bausch + Lomb Stellaris Elite™ 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 Stellaris Elite™ Vision Enhancement System configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty. The Bausch + Lomb Light Pipes are intended for use with the Bausch + Lomb Stellaris Vision Enhancement Systems for use during anterior and posterior segment surgeries. # 7 Summary of Technological Characteristics The following tables compare the subject devices, gamma-sterilized Stellaris Elite™ Packs and X-Pack Procedure Packs and the Light Pipe pouched with the ESA, to the predicate procedure packs of the Stellaris Elite™ vision enhancement systems. The technological characteristics of the Stellaris Elite™ vision enhancement system's reconfigured gamma-sterilized procedure packs and EO-sterilized Light Pipe and ESA pouches are substantially equivalent to the predicate devices. | Table 2: Substantial Equivalence Table for Subject Stellaris Elite™ and Stellaris PC (X-pack) Posterior and Combined Procedure Packs and Light Pipes, Predicate Stellaris Elite™ Vision Enhancement System (K162342) | | | | | --- | --- | --- | --- | | Characteristic/ Parameter | Predicate Device: Stellaris Elite™ Vision Enhancement System (K162342) | Subject Device: Posterior And Combined Procedure Packs, and Light Pipes | Equivalency Analysis | | Manufacturer | Bausch + Lomb, Inc | Same as Predicate Device | N/A | | Regulation Number and Product Code | 21 CFR 886.4670 (HQC) 21 CFR 886.4150 (HQE) 21 CFR 886.4390 (HQF) | Procedure Packs: 21 CFR 886.4670 (HQC) 21 CFR 886.4150 (HQE) Light Pipes: 21 CFR 876.1500 (MPA) | Identical | | Device Class | II | II | Identical | | Intended Use | Anterior/Posterior ophthalmic surgery | Procedure Packs: The Bausch + Lomb posterior/combined procedure packs contain a combination of components necessary for ophthalmic surgery and are intended for vitrectomy during posterior segment surgery. The Bausch + Lomb combined procedure packs are also intended for phacoemulsification of an opacified crystalline lens during combined surgery. | Same | Premarket Notification Special 510(k) Stellaris Elite™ vision enhancement system 510(k) Summary {8} BAUSCH + LOMB See better. Live better. 510(k) Summary - K261264 | Table 2: Substantial Equivalence Table for Subject Stellaris Elite™ and Stellaris PC (X-pack) Posterior and Combined Procedure Packs and Light Pipes, Predicate Stellaris Elite™ Vision Enhancement System (K162342) | | | | | --- | --- | --- | --- | | Characteristic/Parameter | Predicate Device: Stellaris Elite™ Vision Enhancement System (K162342) | Subject Device: Posterior And Combined Procedure Packs, and Light Pipes | Equivalency Analysis | | | | Light Pipes: The Bausch + Lomb Light Pipes are intended to transmit light to the intraocular space during ophthalmic surgery. | | | Indications for Use | The Bausch + Lomb Stellaris Elite™ 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 Stellaris Elite™ Vision Enhancement System configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty. | Procedure Packs: The Bausch + Lomb Stellaris Elite™ 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 Stellaris Elite™ Vision Enhancement System configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty. The Bausch + Lomb posterior and combined procedure packs are intended for use with the Bausch + Lomb Stellaris Vision Enhancement Systems which are intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. They provide capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, vitrectomy, and air/fluid exchange operations. Light Pipes: The Bausch + Lomb Stellaris Elite™ Vision Enhancement System is intended for the emulsification and removal of cataracts, anterior and posterior | Same | Premarket Notification Special 510(k) Stellaris Elite™ vision enhancement system 510(k) Summary Page 4 of 5 {9} BAUSCH + LOMB See better. Live better. 510(k) Summary - K261264 | Table 2: Substantial Equivalence Table for Subject Stellaris Elite™ and Stellaris PC (X-pack) Posterior and Combined Procedure Packs and Light Pipes, Predicate Stellaris Elite™ Vision Enhancement System (K162342) | | | | | --- | --- | --- | --- | | Characteristic/ Parameter | Predicate Device: Stellaris Elite™ Vision Enhancement System (K162342) | Subject Device: Posterior And Combined Procedure Packs, and Light Pipes | Equivalency Analysis | | | | 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 Stellaris Elite™ Vision Enhancement System configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty. The Bausch + Lomb Light Pipes are intended for use with the Bausch + Lomb Stellaris Vision Enhancement Systems for use during anterior and posterior segment surgeries. | | | Contents | Posterior/combined procedure packs contain a combination of components and accessories, including a Light Pipe, necessary for ophthalmic surgery. | Same as Predicate Device | Similar differences not affecting substantial equivalence, safety or performance | | Gauge Sizes | 23, 25, 27 gauge | Same as Predicate Device | Identical | | Materials (Direct/Indirect Patient Contacting) | Materials of construction are biocompatible. | Same as Predicate Device | Identical | | Packaging Configuration | High-Impact Polystyrene (HIPS) tray sealed with a Tyvek lid | Procedure Packs: Same as Predicate Device Light Pipes: Tyvek and Mylar film pouch | Similar, differences not affecting substantial equivalence, safety or performance | | Shelf Life | 36-months | 18-months | Similar, differences not affecting substantial equivalence, safety or performance. | | Single-Use | Yes | Same as Predicate Device | Identical | | Provided Sterile | Yes | Same as Predicate Device | Identical | | Sterilization Method | Gamma Irradiation or Ethylene Oxide | Procedure Packs: Gamma Irradiation | Same, differences not affecting substantial equivalence, safety | Premarket Notification Special 510(k) Stellaris Elite™ vision enhancement system 510(k) Summary Page 5 of 6 {10} BAUSCH + LOMB See better. Live better. 510(k) Summary - K261264 | Table 2: Substantial Equivalence Table for Subject Stellaris Elite™ and Stellaris PC (X-pack) Posterior and Combined Procedure Packs and Light Pipes, Predicate Stellaris Elite™ Vision Enhancement System (K162342) | | | | | --- | --- | --- | --- | | Characteristic/Parameter | Predicate Device: Stellaris Elite™ Vision Enhancement System (K162342) | Subject Device: Posterior And Combined Procedure Packs, and Light Pipes | Equivalency Analysis | | | | Light Pipes: Ethylene Oxide | or performance. | | Sterilization Dose (kGy) | 25-50 kGy | Same as Predicate Device | Identical | | Sterility Assurance Level (SAL) | 10-6 | Same as Predicate Device | Identical | | Biocompatibility | Testing in accordance with ISO 10993-1:2018 guidance and FDA Guidance: Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process | Same as Predicate Device | Identical | ## 8 Summary of Nonclinical Tests and Results ### Transportation Testing Transportation and Packaging assessment for the reconfigured procedure packs was performed in accordance with ISO 11607-1:2019. Transportation testing for the EO-sterilized pouches was performed in accordance with ISO 11607-1:2019 and ISO 11607-2:2019. Test results satisfied the acceptance criteria as defined by the associated ISO standard. Testing passed. ### Sterilization Validation Sterilization validation of the reconfigured gamma-sterilized procedure packs was performed in accordance with the requirements of EN ISO 11137-2. Sterilization validation of the EO-sterilized pouches was performed in accordance with 11135:2014+A1:2019. Test results satisfied the acceptance criteria as defined by the associated ISO standard. Testing passed. ### Biocompatibility Testing Biocompatibility assessments for the reconfigured gamma-sterilized procedure packs and Light Pipe pouches, were performed in accordance with the requirements of ISO 10993-1 to evaluate the impact of the patient contacting material. Test results satisfied the acceptance criteria as defined by the associated ISO standard. Testing passed. ### Non-Clinical Performance Data Non-clinical performance testing was performed to establish substantial equivalence between the predicate device and the revisions as identified within this premarket notification for phacoemulsification and vitrectomy procedures. Testing passed. Premarket Notification Special 510(k) Stellaris Elite™ vision enhancement system 510(k) Summary {11} BAUSCH + LOMB See better. Live better. 510(k) Summary - K261264 ## 9 Summary of Animal/Clinical Tests and Results ### Animal/Clinical Studies No Animal or Clinical Study was performed. ## 10 Conclusion The subject devices have the same intended use as the predicate devices and similar technological characteristics. The differences in technological characteristics do not raise new or different questions of safety and performance. Based on the results of the risk assessment and all applicable testing, the subject devices are determined to perform as intended during normal intended use for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. Therefore, the subject devices meet all applicable requirements for substantial equivalence when compared to the predicate devices. Premarket Notification Special 510(k) Stellaris Elite™ vision enhancement system 510(k) Summary Page 7 of 7 --- **Source:** [https://fda.innolitics.com/device/K261264](https://fda.innolitics.com/device/K261264) **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. 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